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About Michael Anisfeld
(Top Expert on this page)

Expertise
Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

Experience

Past/Present Clients
UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries

   

You are here:  Experts > Health/Fitness > Pharmacology > Pharmaceuticals

Questions Answered By Expert  Michael Anisfeld 
In Category  Pharmaceuticals

SubjectDate Asked

Raw material testing11/4/2009
  Q: Reading guidelines about raw material testing for the pharmaceutical industry, I often find the word ...
  A: The amount of testing is based on the supplier history and your confidence in the Supplier's ...
Required pressure on manometers10/30/2009
  Q: Respected sir please send me a map of ideal ware house for pharmaceutical industry , where we could ...
  A: Why do you need to read pressure in warehouses? The key issue is temperature. If you are trying to ...
Retain Samples10/28/2009
  Q: I am trying to determine if there are any rules FDA/Foreign that would require a retain sample for ...
  A: Interesting questions. 21CFR211.170 on Reserve Samples states: "(b) An appropriately identified ...
Off-label prescriptions10/27/2009
  Q: I know that the FDA cannot regulate a physician's prescribing FDA approved drugs for off-label uses, ...
  A: Claire: You appear to be correct (but as I am not a lawyer, I cannot state that you legally "are ...
MAP OF DEDICATED WARE HOUSE (RAW , PACKING AND F/G )10/26/2009
  Q: Respected sir please send me a map of ideal ware house for pharmaceutical industry , where we could ...
  A: There is no such thing as the "ideal" warehouse, as it depends on your product needs (degree of ...
Raw Material Sampling10/15/2009
  Q: Is there any guideline which cites the quantity for Raw material sampling? Or from where this root ...
  A: You are asking two different questions. For chemicals you need to sample sufficient material to ...
API10/13/2009
  Q: my question is how we give expiry date to a finished dose form product, and if we have an API lot ...
  A: With the exception of products sold in India (they have a unique interpretation of API stability and ...
Temperature and humidity requirement for multi vitamins and pharmaceutical excepients10/5/2009
  Q: Respected sir i am employee of a pharmaceutical company as manager stores. would you like to brief ...
  A: The temperature/humidty requirements required in your warehouse will relate to what you are storing. ...
Ideal and dedicated map of raw , packing ang finished goods stores in pharmaceutical industry9/29/2009
  Q: Respected sir i am employee of a pharmaceutical company as manager stores. would you like to brief ...
  A: You need separate areas for: a. goods receipt (unloading dock) b. raw material sampling area (a ...
GMP Specifications for Relative humidity and temperature.9/28/2009
  Q: Please what are the various classes of areas in the pharmaceutical manufacturing plant with ...
  A: According to the USP (Genral Notices), the following definitions apply: Freezer— A place in which ...
Stability testing pulling times9/28/2009
  Q: I was wandering whether you could help with my query relating to stability testing of ...
  A: The answers you seek were covered in an FDA OGD Guideline, withdrawn a few years ago. Samples with ...
Pharmaceuticals7/2/2009
  Q: Have a nice Day My question is: Can we give Retesting date to Raw Material beyond its expiry date ...
  A: The only GMP providing guidance on this, worldwide, is the Canadian GMPs. They state that if the ...
Expiry date vs date of manufacture vs shelf life6/24/2009
  Q: My question is regarding expiry dating which is usually expressed as month and year. If a pharma ...
  A: Kevin: The date of manufacture is the date that the ingredients first get to meet each other, say ...
Reprocess of nearing expiry drug substance6/22/2009
  Q: One of my friends wants to reprocess the nearing expiry drug substance. If he does, then What would ...
  A: you can do this on two conditions: a. you have stability data (at a minimum 6 months accelerated ...
Microbiological testing of pharmaceutical stability samples11/5/2008
  Q: I saw your answer regarding the frequency of testing for stability and wonder if microbiological ...
  A: If the study is to establish an expiration date for a new product, then microbial testing is ...
zaleplon10/30/2008
  Q: Can you tell me how to obtain zaleplon in Canada? It used to be available as Starnoc, but appears ...
  A: Humble and profuse apologies. I was mixing the drug in my mind with Zolpidem (sold here as Ambien) ...
zaleplon10/29/2008
  Q: Can you tell me how to obtain zaleplon in Canada? It used to be available as Starnoc, but appears ...
  A: Zaleplon is sold in the USA as Ambien. It is banned in Canada and is not available there. I ...
Vertical form fill seal machines10/7/2008
  Q: We are trying to place powdered nutritional supplements into a 3 or 4 sided pouch. It is a fine ...
  A: Vicki: Many moons ago I used to run a powder fill line for pharmaceutical products, and will share ...
microbiological testing in pharmaceuticals9/23/2008
  Q: Can I get rid off Autoclave if I use 'ready to use media / plates/ tubes' in the microbiological ...
  A: JK: I wish you could, but have you thought about how you will decontaminate the growth plates after ...
Brand Name Synthroid vs. Generic9/22/2008
  Q: My doctor, who I respect, and his entire endocrinology practice at a major Baltimore hospital, ...
  A: As the FDA has approved generic Synthroid as bio-equivalent to the original brand, you will have a ...
Freeze Thaw Study9/20/2008
  Q: I would like to know how is freeze/thaw study carried out for Liquid oral products with references, ...
  A: Take your liquid product, cool at -5oC to freeze, and hold frozen for 24 hours; then thaw at room ...
Drug Safety9/18/2008
  Q: I get extremely intense anxiety when flying on airplanes. A few years ago, I went to a doctor and ...
  A: All drugs degrade from the date of manufacture, losing effectiveness and potentially building up ...
Clonidine and Atenolol manufacturing9/12/2008
  Q: I have a question about these two medications. My mother takes both for her high blood pressure and ...
  A: Sheryl: Welcome to the wonderful world of generic drugs. When the product patent expires, ...
Quality Index in pharmaceuticals8/21/2008
  Q: What is quality index.pls give the importance of it.Is their any reference for this.
  A: There is no uniform definition, and many people use the term in may different ways. As examples, ...
writing the dossier when only CEP is available8/12/2008
  Q: I have a problem, I need to write a registration documentation in EU format (not CTD) - the IIF ...
  A: I commiserate with you, having been in the same situation a few years back. The EU reviewers demand ...
stability/balance calibration7/26/2008
  Q: stability what to do if our product shows significant change in accelerated condition calibration ...
  A: stability - by "change" in stability - do you mean that the product does not meet its specification ...
generic drugs -- not quite the same7/23/2008
  Q: Are you aware, that by law, generic drugs do not have to bioidentical? Meaning they can contain ...
  A: Lori: Sorry, but I completely disagree with you. According to the Good Manufacturing Practices ...
Hi7/10/2008
  Q: Can you suggest me what is most acceptable date format or most suited date format in Industry ...
  A: Most of the industry uses the ISO Standard date format. This is YYYY-MMM-DD. So today's date July ...
Hi7/10/2008
  Q: Not for any question, But I got your profile so contacted We met at Artemis Biotech, Hyderabad; ...
  A: Soni: Yes indeed I do remember you. What are you doing now and how is it going? Incidentally, what ...
Sampling conditions for non sterile raw materials7/10/2008
  Q: I wanted to know if there are any environmental conditions that should be adhered to for non ...
  A: Sampling for chemical testing is routinely performed in a Class 100,000 (ISO Class 8) environment. ...
Stability samples transfer7/9/2008
  Q: I would like to know is it ok to transfer a stability study from one country to another during the ...
  A: In principle I do not see any problem with this except one. The transportation issues are not of ...
FBD bag6/6/2008
  Q: I would like to know about the "material Of Construction" (MOC) of FBD bag. Thank you very much, ...
  A: You must, I repeat MUST, personally audit the bag fabricator - and take someone with you who knows ...
Shelf life of Chantix...5/20/2008
  Q: My girlfriend is taking Chantix. She has a prescription of course (and it seems to be working!). ...
  A: Look at the outside of the carton the Chantix came in. If the expiration date is still within its ...
amoxicillin/clavulanic acid5/20/2008
  Q: just wanted to ask what exactly is this medication. I tried to look it up but couldn't find ...
  A: It is a very effective broad spectrum antibiotic. If you Google Augmentin, (make sure you spell it ...
new energy vitamin5/2/2008
  Q: what is the best way to get my new energy vitamin produced. I know there are thousands of vitamin ...
  A: The best way would be to find an existing Vitamin manufacturer who is willing to engage in contact ...
Bulk product stability5/1/2008
  Q: We are using Hexagonal Corrugated boxes with double lined polybags with a desccant bag in between to ...
  A: Sorry, but I need clarification in order to answer. The Hexagonal Corrugated Boxes - are they used ...
Stability4/30/2008
  Q: "Dear Mr.Michael/ Ihope that you are in the best mode: I have two questions: 1)If time for ...
  A: Q1. Seems like you are tying yourself in knots about this. The key question you really need to ask ...
Stability4/30/2008
  Q: "Dear Mr.Michael/ Ihope that you are in the best mode: I have two questions: 1)If time for ...
  A: Moayyad: You hope I am in the "best mode" - I am not sure what you mean my this, but I am fine - ...
Raw Material storage requirements4/29/2008
  Q: what is meant by "Store in cool and dry place" in pharmaceutical raw material storage. We often use ...
  A: Irfan: According to USP definitions (USP31): "Cool" — Any temperature between 8oC and 15oC (46 ...
test or no the bulk?4/10/2008
  Q: A bulk of tablets was made 2 months ago. It has been waiting since then to be put in the primary ...
  A: FDA allows up to 30 days storage without the need for supporting stability data on the bulk. as such ...
preparation of two batches4/7/2008
  Q: please is it comply to GMP to prepared batche in one holding tank and filled in to two different ...
  A: A batch is defined as a homogenous mixture. As such your single tank formulation is ONE batch. When ...
Endotoxin3/20/2008
  Q: What is the significance of testing endotoxins in parentral preperation .the normal limit is found ...
  A: The presence of endotoxins can cause a cascade of body reactions/degradations leading to death ...
bulk stability3/12/2008
  Q: We would like to complete bulk stability on our drug product (and/or intermediates) in small fibre ...
  A: If you drug product is an "active pharmaceutical ingredient" (API), then you can keep your stability ...
Pharmaceuticals3/3/2008
  Q: we have our client in US having 300 geriatric home with 300 nursing homes and pharmacies they want ...
  A: For you to export to the USA (and it does not matter that you are selling directly to nursing ...
Filter Validation2/28/2008
  Q: What is filter validation? What does it inlcudes and When it is required?
  A: Filter validation relates to studies to demonstrate the suitability of the filter selected for use. ...
UV pass box validation2/21/2008
  Q: Do we need to validate the time of UV exposure in the pass box? Since all sterilized materials, ...
  A: UV is not used in passboxes in the USA or in Europe. Better to double wrap the materials being ...
GMP certificate validity period2/14/2008
  Q: I was wanting to ask this since a long time....the USFDA GMP certificate does not bear a validity ...
  A: FDA Certificates of GMP do not bear expiration dates because FDA has the attitude that the facility ...
freeze/thaw study necessary1/25/2008
  Q: We make OTC products (e.g. antiperspirants, dandruff shampoos, zinc oxide, enema, oral laxative, ...
  A: I used to make these types of products, and we often had customer complaints due to product ...
UV Pass box1/22/2008
  Q: As it is well known, Uv radiations are not 100 % effective, if used alone as surfaces sanitizing ...
  A: The pass-through is a closed box. When you open it to place material in from the "C" (dirty) side, ...
UV Pass box1/22/2008
  Q: As it is well known, Uv radiations are not 100 % effective, if used alone as surfaces sanitizing ...
  A: Your proposal is "interesting" and very strange. If the materials are double bagged in sterile ...
drug exports1/21/2008
  Q: What license is required to manufacture prescription drugs in the US for export only to the EU? ...
  A: Kevin: If you are starting from scratch, then figure 2-3 years to build/equip/validate a facility; ...
drug exports1/20/2008
  Q: What license is required to manufacture prescription drugs in the US for export only to the EU?
  A: It makes no difference whether the drug manufactured in the USA is for domestic sale only, or for ...
Stability Commitment1/17/2008
  Q: A three years ago, we received approval for a product and the first three production batches were ...
  A: If absolutely nothing, and I do mean nothing, has changed, then there is no need to repeat the long ...
quality control in pharma12/30/2007
  Q: HOW i can i address failure in analytical instruments calibration failure
  A: If an analytical instrument fails its calibration (is out-of-tolerance), then you need to do the ...
pharmasceuticals calibrations12/30/2007
  Q: How calibration of analytical instruments address
  A: Calibration of instrumentation requires three things: a. use of a reference standard that is ...
Bulk Stability11/29/2007
  Q: We are using very large pails (0.75 cubic meters volume)to hold our solid dosage products before ...
  A: if the water vapor transmission rate of the wall of the smaller pail equals that of the bigger pail, ...
Bulk Stability11/28/2007
  Q: We are using very large pails (0.75 cubic meters volume)to hold our solid dosage products before ...
  A: The critical questions are: a. how are the bulk pails sealed, and b. what are the storage ...
Retained samples11/15/2007
  Q: I want to ask about retained samples.When the drug product packed it may have many consignees.Is it ...
  A: It frequently happens that a single batch of product is packed in the same primary packaging, but ...
Retesting of raw materials11/7/2007
  Q: Is it accepted to retest the raw materials (API's/ inactives) when it's reach the "expiration date" ...
  A: Under ICH-Q7 (GMPs for APIs) all APIs and by extension excipients) should have "retest dates". When ...
Why 2-theta and not theta?10/11/2007
  Q: Why is the X-axis in P-XRD chromatograms expressed in 2-theta instead of theta?
  A: Rubi: My sincere apologies, but my expertise does not extend to in-depth chemical analysis, ...
Export of UK/EU licensed product to USA9/21/2007
  Q: Can I export UK/EU licenced product to the US for sale?
  A: No. You can only export pharmaceutical products (from anywhere in the world) into the USA, when the ...
Analytical method development9/11/2007
  Q: How to ensure that all the known and unknown impurities of the sample are dissolved in specified ...
  A: Great Question. The answer is entirely found under the "forced degradation" section of the ICH ...
DMF grade APIs9/5/2007
  Q: Is DMF grade API different from any standard pharmacopoeia like US/NF or BP ? If yes can it be ...
  A: There is no such thing as "DMF grade". APIs are manufactured to pharmacopoeia standards. DMF (Drug ...
Augmetin/erythromycin in Jungle and Africa8/19/2007
  Q: How long can erythromycin and Augmentin last in the bottles that are dispensed from the pharmacy? ...
  A: Mark: I sympathize, I too travel a lot to Africa and South East Asia, and have the same exact ...
DMF proceedure8/16/2007
  Q: How does DMF filing works? is it required for both generics & patented drugs? what does a successful ...
  A: A Drug Master File (DMF) is a way of advising FDA of the manufacture and controls in place, to make ...
UV Sterilization in Pass Box7/16/2007
  Q: Our company design and manufactures Pass Boxes for Cleanrooms. Recently we have been asked to ...
  A: Steven: UV lamp pass-throughs have been long ago abandoned in the US and Europe as effective ...
UV Box Validation6/27/2007
  Q: My company has an UV box that where use to bass eye drops containers, the eye drops containers is ...
  A: 1. sorry but I do not understand your comment - pls rephrase it; 2. you can use 70% isopropanol as ...
Reg : Validation batches6/14/2007
  Q: I would like to know whether validation batches can be sold in the local market or is it compulsory ...
  A: In the USA - if all the validation batches (a minimum of 3) pass all the protocol criteria, the ...
Process validation6/9/2007
  Q: Is there any legal regulation require studying the first three production batches of a product under ...
  A: There is a legal requirement in the US and EU that 3 stability batches be prepared, and that 3 ...
expired benzodiazapines5/29/2007
  Q: i have a full bottle of xanax that was prescribed in 1998 that was left untouched. what would they ...
  A: Dump them. do not take. As the active ingredient in the Xanax degrades, impurities build up which ...
Expired Marcobid5/28/2007
  Q: I hope you can answer this - I woke up with a blazing case of Urinary Tract Infection. Of course ...
  A: When drugs go beyond their expiration date two things happen: a. the active drug degrades, so there ...
Stability study samples5/22/2007
  Q: Anisfeld Regarding the withdrawn stability study samples at study points, what is the allowable ...
  A: The timings I provided came from an old FDA guideline from FDA's Office of General Drugs. ...
Stability study samples5/20/2007
  Q: Anisfeld Regarding the withdrawn stability study samples at study points, what is the allowable ...
  A: 1, 2, and 3 months samples should be withdrawn and tested with 3 days of the target date; 6, 9, and ...
Ery-Tab 500 mg4/9/2007
  Q: What is the actual shelf life of erythromycin? I have a bottle that was filled 2-10-06, with ...
  A: The shelf life (expiration date) of erythromycin can be 1 or 2 years depending on the manufacturer's ...
M.Sc. Pharm Validation Course3/27/2007
  Q: How valuable would the following course be in the pharma industry, how good of a job would one get? ...
  A: Your citizenship is not an issue in the pharmaceutical industry, it is however an issue in getting a ...
generic3/2/2007
  Q: are there any differences between generic and brand name drugs? To be more specific: lamictal vs. ...
  A: To sell a generic drug, the manufacturer needs to prove to the FDA that the generic is bioequivalent ...
expiration date meds1/5/2007
  Q: I've been on prednisone off and on for years as treatment for Crohn's disease. I currently have ...
  A: Kathy: Your pharmacist has a record of the batch number of the prescription that was filled in ...
Alternate to Zolpidem (Ambien) on Canada1/2/2007
  Q: Do you have any idea why my family physician and pharmacist don't know what it is? And what is the ...
  A: I have no idea why your local resources do not know about this. The drug is available under the name ...
Calibration curve12/20/2006
  Q: A question regarding standard concentrations within a calibration curve. If you are going to build ...
  A: Most folks will build their calibration curve with standards at 25%, 50%, 75%, and 100% (some folks ...
difference12/13/2006
  Q: what is the difference between drug contraindication and a drug precaution?
  A: A drug contraindication spells out under what conditions the drug should not be used (e.g. ...
Stability Chamber Excursion11/28/2006
  Q: Question regarding how to document when we encounter an excursion in the temperature or humidity in ...
  A: Steve: a. when you have a temp/humidity excursion you do not have a deviation, you have an ...
Ambien/Zolpidem11/15/2006
  Q: It appears that no form of Zolpidem is available in Canada. I am wondering if there are any ...
  A: Canada is not the only source of "good" medication available on the Internet. You can also try ...
saline11/6/2006
  Q: Can you tell me the difference between injectible saline and saline used to treat nasal dryness or ...
  A: Injectable saline is sterile, while nasal or other saline is not. The danger you have of injecting ...
Expiry dates for Drugs10/30/2006
  Q: I have the following in my medicine cabinet and I was wondering what the shelf life would be. 1. ...
  A: Glenda: Most drugs have a two year shelf life, so for the 2004 material - sorry, but junk it. For ...
Qualification of Autoclave10/27/2006
  Q: USP general Chapters for microbiological testing requires to perfrom temperature mapping of the ...
  A: Three alternatives are available for temperature profiling "old" 'claves: a. purchase a set of ...
Cleaning10/13/2006
  Q: What is the best way to clean a tablet compressor machine? Is there any chemical which is allowed?
  A: You can use any cleaning agent you like as long as: a. it does not interact (e.g. corrode) the ...
Citrate in Calcium Citrate9/17/2006
  Q: From where is the citrate part of this formulation derived? Is it from natural sources, or can it ...
  A: Calcium citrate can be extracted from natural sources (with variable impurities and impurity levels ...
Temperature Cycling Studies9/15/2006
  Q: We generally do Freeze/Thaw studies to determine the impact of extreme environmental (Temp, ...
  A: I am currently on assignment in China and do not have access to my library. I have done freeze/thaw ...
Stability Chambers9/5/2006
  Q: If the temperature or humidity drops during an excursion in a stability chamber for an extended ...
  A: Sunil: This is where your accelerated stability studies can provide information as to the impac of ...
Penicillin9/2/2006
  Q: Could a layman such as a medical student make Penicillin?
  A: James: Sure you could, assuming you find the correct strain of organism, and evolve optimum ...
Comarision of US drugs to Canadian7/26/2006
  Q: I am currently taking a US drug [Fosamax] I can save a lot of money by purchasing it by mail order ...
  A: Yes you can be sure that the drug is the same, but you need to be sure that you are not getting a ...
Machine operator7/23/2006
  Q: Is it allowed for a tablet compressor operator to operate two machines manufacturing two different ...
  A: Assuming that the two tablets compressors are working on different products (even the same product ...
drugs7/17/2006
  Q: I would like to know the difference between an opiate and morphine... my daughter takes pain ...
  A: Francesca: An opiate is any drug derived from the Opium poppy. There are over twenty such drugs - ...
Strengths of medicine7/14/2006
  Q: I understand, But does the mscontin have morphine and oxycontin in it ? And therefore would it be ...
  A: 60mg Oxycontin contains only oxycontine 30mg morphien contains only morphine they are just ...
Strengths of medicine7/14/2006
  Q: What medication is stronger ? Morphine 30mg SO4 Or 60mg mscontin
  A: Your question is a little like "which tastes sweeter - an orange or a pineapple?" Morphine and ...
Acne Treatment7/11/2006
  Q: , I would just like to know the differences between Roaccutane and the generics (i.e. acnetane & ...
  A: All drugs, brand name or generic, need to be registered with FDA. In order to sell generic versions ...
medication name changes6/24/2006
  Q: ----Here is rhe URL regaring the above subject matter. Please read and let me know if you still ...
  A: As I said, "I think you have been hoaxed". In fact if you go to the very top of the website that ...
Natural Vitamins6/14/2006
  Q: my doctor says synthetic vitamins are no use at all.my doctor has prescribed vitmain B.He told me to ...
  A: A doctor studies medicine and is an expert in diseases; a pharmacist study drugs and their actions ...
Natural Vitamins6/14/2006
  Q: my doctor has prescribed vitmain B.He told me to get a natural vitmain.What does it mean. Is there ...
  A: Vitamins can be extracted from plants ("naturally derived vitamin"), or manufactured synthically by ...
Sunscreen6/8/2006
  Q: I was told Neutrogena spf30 and spf45 are good protection when applied frequintly. Is this one of ...
  A: The higher the SPF number (Sun Protection Factor), the more sun blocking you get, which means the ...
Stability study6/4/2006
  Q: My inquiry is about redoing stability studies and its causes. I have some cases that may worth ...
  A: Ahmad: If you change the source of your active ingredient, or of your inactive ingredient - you ...
Synthetic/natural ingrediants5/4/2006
  Q: I was told that certain ingredients such as Iron, Folic acid, zinc, etc. can be sythesized in a ...
  A: Teresa: I'm afraid that you are confused about some things: a. naturally occuring elements (iron, ...
Aspirin and Brufen4/22/2006
  Q: I have been trying to find out the relationship between these two analgesics. Are they related in ...
  A: Different chemicals work in different ways to effect the same cure - in this case to releve pain. ...
Drug Identification:3/12/2006
  Q: I found a capsule among my daughters things and can't seem to be able to identify it. It is a light ...
  A: Take the capsule to your local community pharmacy, where they have identification charts and ...
Drug Companies & HELP!3/5/2006
  Q: I was wondering if doctors earn some commission for prescribing drugs (even in nursing homes)? I ...
  A: Pharmaceutical companies spend on average (between all of them) about US$ 7,000 a year on trinkets ...
Pharmacy2/13/2006
  Q: what are some of the first steps to becoming a top knowledged pharmacist?
  A: I do not want to sound fascetious, but the first steps are: 1. go to the best pharmacy school, ...
pharmaceutical science2/11/2006
  Q: What is the role of pharmaceutical science in modern medicine
  A: ensuring that the drug is formulated such that it gets to the correct location in the body in a ...
Novotriptyn2/9/2006
  Q: Anisfeld Thank you for taking my question. I would like to know the shelf life of Novotriptyn and ...
  A: All drug products start to degrade once they are manufactured. The shelf life (expiration dating) is ...
False positive drug tests1/24/2006
  Q: I'm not sure if you can help me, but I was always told it couldn't hurt to ask. I'm a recruiter for ...
  A: Debbie: What you inquire about is a perennial problem; especially when we come to the Olympic ...
Medication Temperature Range1/24/2006
  Q: Michael, Knowing that the medication temperature storage range recommended by the USP is 59-86 ...
  A: Bill: In order to provide a product's exiration date, manufacturers are required to perform ...
plasma expander1/4/2006
  Q: we attempt to build a pharmaceutical factory to produce parenteral solutions .we would be most ...
  A: We are a consulting company that specializes in the design, building, and the start-up of ...
Drug research?11/19/2005
  Q: Let's say, a doctor is seeing a patient who has a history of chest pain, high cholesterol, ...
  A: The quickest and easiest way to study this effect is: a. to a group of patients exhibiting the ...
Flu Vaccine11/12/2005
  Q: How do the experts know what flu virus will be around each year far enough in advance to prepare the ...
  A: There are several strains of influenza virus. Every year the World Health Organization (WHO) makes ...
Business in Pharmacy9/19/2005
  Q: I will end my pharmacy education within the mid. of the next month. Then i want to start my own ...
  A: Without knowing you, your likes and dislikes, how can I even begin to answer that question? All I ...
pill id8/5/2005
  Q: Vintage Pharmaceuticals, an oblong white w/green specks tablet with 3594 printed on one side and the ...
  A: Raymond: In the time it took you to write to me, if you had gone on Google and entered "tablet ...
Manufacture7/19/2005
  Q: Is there a difference in medication makeup between manufacturers? For example, would the active and ...
  A: Kent: Each manufacturer can purchase the active anywhere they want, so long as each active ...
Piercing7/17/2005
  Q: Um I did somehting stupid...I'm 14...I pierced the top of my ear by myself with a needle soaked in ...
  A: Lauren: As a pharmacist, it sounds to me like you might have a very serious ear infection, which ...
Vitamins-Minerals7/5/2005
  Q: I've learned where our soils have been depleted of minerals from wind, leaching, poor farming ...
  A: If the soil were depleted, then the plants would not grow. As a pharmacist I have to tell you that ...
Pharmaceuticals7/4/2005
  Q: 1)What is MOC for filter bags used in FBD.What is the pore size of those bags? Is there any ...
  A: To answer your questions: 1. please elaborate on what is MOC; but companies typically do a visual ...
time release6/25/2005
  Q: what happens when you chew a time released pill? does it all take effect right away or is it still ...
  A: Different time release dosage forms work in different ways. If it the tablet coating that is ...
coumadin/warfarin6/18/2005
  Q: Since your expertise is in manufacturing and technology, answer me this question. Is the ...
  A: If your Coumadin was manufactured by a pharmaceutical company registered with the Mexican ...
film coating6/18/2005
  Q: What we have to do in film coating? Is there any type of aquous coating? What we have to do in ...
  A: Film coating is extremely complex, and an answer is beyond the scope of this forum. The best text ...
Prandin Expiration Dates6/17/2005
  Q: I get Prandin from Liberty Medical and it works fine for me but I notice it always has an expriation ...
  A: No pharmaceutical company would EVER manufacture a drug with a 6 month shelf life (stability); the ...
Lariam6/8/2005
  Q: in a couple of weeks i am going to be deployed as an UN Military Observer in Sudan. I was given a ...
  A: First let me wish you luck on your assignment - and a very diificut one. If I can assist from my ...
drug imports5/18/2005
  Q: I am consulting to a German online pharmacy. They wish to have a list of the top-selling drugs that ...
  A: Richard: I have no idea where such a list can be found, BUT .... there are many sources to find ...
Ferrous Sulohate and Black Faeces5/11/2005
  Q: I know that Ferrous Sulphate tablets cause the stool to turn black but WHY does this occurr? Thanks
  A: Facetously I'd say that you have rusty stools. No, but seriously, blood carries oxygen, but needs ...
user requirements and designe qualifications4/13/2005
  Q: how are the URS detremined, then how can we review the designe(how can we qualify the design?), ...
  A: User Requirement Specifications (URS) relates to equipment; and are determined by you, based on what ...
hi4/7/2005
  Q: Good morning,could u please tell me the name of science dealing with cream synthesis and are there ...
  A: The science of the properties of creams in termed "rheology". There is no specific name for the ...
Protonix vs. Nexium3/27/2005
  Q: When my medical clinic changed my priscription from "prilosec" to "nexium", It was my understanding ...
  A: Donald: Nexium is Astra-Zeneca's confidence trick on the US public. Nexium is the optical isomer of ...
vaccine production process2/15/2005
  Q: This statement was made on an on-line forum. Is it true? What I am interested in is if aborted ...
  A: Absolute BULL! I worked for a company making these vaccines. They are grown on chicken eggs - we ...
Identify Slimming pill2/14/2005
  Q: I ordered from a medical company over the internet 1 mths supply of Phentermine (generic). I have ...
  A: I am a member of the World Health Organization anti-counterfeit drugs task force. What you describe ...
free foreign generics1/30/2005
  Q: and thanks for taking my question. After reading 'Mountains Beyond Mountains,' I began thinking more ...
  A: You've just got your facts plain wrong. When a drug goes off patent, someone still has to make it ...
lifesaverforu@yahoo.com1/8/2005
  Q: sir how many mg or micro grams are equal to one I.U? e.g.how many mg are found in one I.U of vit D? ...
  A: You are confusing two units of measure - IU is activity, mg is weight. In many drugs you express ...
Lortab12/15/2004
  Q: My grandmother has been diagnosed with pancreatic cancer and has been prescribed Lortab for pain; ...
  A: Yes, you can crush the tablets. Also you can dissolve the now crushed tablet - the powder - in ...
Dear Michael, What happens...12/4/2004
  Q: What happens when someone orders prescription medication online from another country? What are the ...
  A: Thea: You can order medication on the internet, however there is a very good chance that your ...
Dilantin11/13/2004
  Q: My wife has taken dilantin for several years due to a stroke and a seizure disorder. About a year ...
  A: Generic Dilantin has been demonstrated to FDA to be bioequivalent to Phenytoin. Hence scientifically ...
Synagis costs11/12/2004
  Q: Can you tell me why Medimunne can charge so much money for the RSV vaccine for my child? Is there ...
  A: The USA is the only country in the world that does not, as government policy, cap the price of drugs ...
Pharcmacy Tech.11/12/2004
  Q: before looking at shcools, i'm interested in be coming a Pharmacy tech do you know their yearly ...
  A: Sorry I only make the drugs, I do not dispense them, so I have no answer to your question. But a ...
i was just wondering if you...10/13/2004
  Q: i was just wondering if you could help me with an assignment that I have started. it was one of ...
  A: Fascinating question, and one that I truely wish I could assist on, but your field is absolutely and ...
Herbal and Alternative Medicines9/27/2004
  Q: ------------------------- Thank you for responding. I guess my question was a little vague. ...
  A: First separate in your mind herbal medication from homeopathic - they are very different. ...
Betadine Surgical Scrub9/17/2004
  Q: For years I have been using Betadine Surgical Scrub for washing myself as I am prone to skin ...
  A: Sorry - I'm too much of a pharmacist, and I missed the obvious. The scrub is a 4% soultion, the ...
Anti Malarial Medication9/11/2004
  Q: My family and I will be travelling to Mexico in November for a month. It is my understanding that, ...
  A: My expertise is in making drugs, not in how they are used; so I am sorry but I cannto assist you. ...
Prescription Drug discount card8/27/2004
  Q: Are you aware of any really significant discount card on the market? I am searching for a ...
  A: Check whether your state has a subsidized drug propgram that you might qualify for; or alternately ...
Suspensions8/18/2004
  Q: I am just trying to find information on products made of gels in pharmacy for a research project and ...
  A: Lib: Two great texts you should consult are: a. "Theory and Practice of Industrial Pharmacy", by ...
drug names7/30/2004
  Q: My wife takes Tegretol XR. Is Tegretol CR, which is sold in Canada the same. If not what is the ...
  A: XR - CR, these are marketing terms. Probably XR stands for eXtended Release, while CR means ...
Armour vs generic thyroid6/26/2004
  Q: Even though I've been told at Wal-Mart that my generic thyroid pill is the same as the Armour ...
  A: Your Wal-Mart generic drug is chemically identical to the brand name, and what you are suffering ...
expired chemicals6/6/2004
  Q: how r u doing?i would like to inquire about the standard way in management of xpired chemical ...
  A: For chemicals beyond their retest date, you can try any of these possibilities: a. do full ...
Penicillin G Procaine6/4/2004
  Q: I am wondering what happens to Penicillin G Procaine if it is not kept at a cool tempurature. In ...
  A: Trevor: Check the storage conditiond stated on the product label, and store it at those temps. If ...
generic vs brand med5/12/2004
  Q: Hope I'm in the right dept. with my question, here goes: I'm 59, female... diagnosis= ...
  A: Regretfully your pharmacist might be an expert on the actions of drugs but he/she knows very little ...
A Theory on Drug Abuse4/13/2004
  Q: I have heard a theory on talk radio recently that there will always be about a 10% drug ...
  A: Regretfully I have never heard of this theory and could not comment on it. But what I would say is ...
wrong prescription3/30/2004
  Q: I recently moved to Texas, and due to worsening allergies, was prescribed Singular 10. However, ...
  A: Wendy: What I suggest you do is: a. speak to your physician and get his input into this eggregious ...
Pharmaceutical Fish Oil?1/29/2004
  Q: I have read recently recommendations from various people about using "pharmaceutical fish oil" as ...
  A: In thirty years working in pharmacy, I have never heard the term "pharmaceutical fish oil". If by ...
Generic Pharmacutical Quality Assurance1/12/2004
  Q: Micheal, Originally I was given samples of Alprazolam .500mcg from my Doctor. These samples were ...
  A: Several things could be going on here: a. your doctor could have changed the medication without ...
Possible drug misdose.12/17/2003
  Q: I was recently prescribed an antibiotic for occasional acne breakouts. Upon taking this I ...
  A: With all medications the amount of drug stated on the label (in your case 100mg) refers to the ...
help10/5/2003
  Q: heres a sentence from a job spec i have an interview for soon. "Aside from the release testing ...
  A: The sentence refers to analytical testing that is required to comply with FDA drug manufacturing and ...
Good Storage Practice in pharmaceutical industry8/19/2003
  Q: i would like to inquire about a certain issue related to GMP requirments; Is there any document or ...
  A: Sorry for the delay in responding, but I have just today got back from 10 days without internet ...

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