Apr 9, 2004 14:34
20 yrs ago
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English term
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Native in: Chinese 
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compendial
English
Medical
Medical: Pharmaceuticals
Context: All ingredients (of a care solutions of contact lens) are compendial. Does compendial mean it is contained in pharmacopoeia ? Thank You! Please tell me in plain English. Thanks!
Responses
+3
44 mins
Melanie Nassar
United States
United States
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English
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United States
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Native in: English
Works in: German to English, English, English to German, and 1 more.
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contained in a compendium (list)
I think your guess is correct, compendial ingredients are ingredients which are included in a list of some kind.
Compendium
(n.) A brief compilation or composition, containing the principal heads, or general principles, of a larger work or system
see this FDA site about drug testing:
Inactive ingredients- Compendial or non-compendial. For compendial ingredients, analytical methods and acceptance criteria recognized in official compendia should be referenced.
http://www.fda.gov/cder/present/chem-dk/tsld022.htm
Compendium
(n.) A brief compilation or composition, containing the principal heads, or general principles, of a larger work or system
see this FDA site about drug testing:
Inactive ingredients- Compendial or non-compendial. For compendial ingredients, analytical methods and acceptance criteria recognized in official compendia should be referenced.
http://www.fda.gov/cder/present/chem-dk/tsld022.htm
Peer comment(s):
| agree |
Vicky Papaprodromou
0 min
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| agree |
Jörgen Slet
6 hrs
|
| agree |
Hadiyono Jaqin
1758 days
|
4 KudoZ points awarded for this answer.
Comment: "Graded automatically based on peer agreement."
58 mins
article recongnized in official pharmacopeia or standards
"Compendial tests are performed to determine if the material's specifications are met and/or to address anticipated regulatory concerns. These test series can also be applied to determine general drug compatibility or for routine quality control"
http://www.westpharma.com/services/contract_labs/routine_tes...
The ingredients have been tested (compendial test) and they are recognized in official pharmacopeia and meet specific quality standards.
http://www.westpharma.com/services/contract_labs/routine_tes...
The ingredients have been tested (compendial test) and they are recognized in official pharmacopeia and meet specific quality standards.
1 hr
Compendial Products (CPG 7132.05) FDA aproved
Compendial tests are performed to determine if the material's specifications are met and/or to address anticipated regulatory concerns. These test series can also be applied to determine general drug compatibility or for routine quality control.
There have been inquiries from the field and industry concerning the following four items as they apply to the manufacture of compendial (USP/NF) drug products.
1. Does a firm have to use the compendial methodology on a batch release basis, to determine whether its product meets the requirements of the monograph?
2. Does the word, "specifications" as used in 21 CFR 211.165 refer to compendial specifications or those set up by the firm's quality control unit?
3. Does a firm have to test for all requirements listed in the monograph for a compendial product?
4. Are the compendial testing requirements the same for products destined for the commercial market and the military?
http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg420-400....
There have been inquiries from the field and industry concerning the following four items as they apply to the manufacture of compendial (USP/NF) drug products.
1. Does a firm have to use the compendial methodology on a batch release basis, to determine whether its product meets the requirements of the monograph?
2. Does the word, "specifications" as used in 21 CFR 211.165 refer to compendial specifications or those set up by the firm's quality control unit?
3. Does a firm have to test for all requirements listed in the monograph for a compendial product?
4. Are the compendial testing requirements the same for products destined for the commercial market and the military?
http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg420-400....
Reference:
http://www.westpharma.com/services/contract_labs/routine_testing.asp
http://www.fda.gov/ohrms/dockets/ac/02/slides/3841s1_07_lachman/sld032.htm
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