Bulk drug substance definition
[DOC File]Amiloride TOBI study
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2.1 Components of the Drug Product. 2.1.1 Drug Substance. The physicochemical and biological properties of the drug substance that can influence the performance of the drug product and its manufacturability, or were specifically designed into the drug substance (e.g., solid state properties), should be identified and discussed.
[DOCX File]13-3401; Definitions
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Feb 05, 2003 · Green Sheet The CONTROLLED SUBSTANCE ADMINISTRATION RECORD (VA Form 10-2638) is referred to as a Green Sheet or GS throughout the Controlled Substances V. 3.0 package. Pharmacy dispensing number, drug name, expiration date, quantity dispensed, lot number, ordered by, dispensed by, and ward (NAOU) are printed on the form.
[DOCX File]Chapter 34 of Title 54 - Virginia
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Drug substance. The drug substance used for preparation of [Product] is bulk [Product]. The chemical name is [Product]. [Product] is a yellow to greenish yellow, odorless or practically odorless crystalline compound, soluble in water. It is the salt of a moderately strong base, [Product], pKa 8.7. The drug substance is being purchased from ...
[DOC File]ICH E10
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The QOS should also summarise the impurity levels in batches of the drug substance used in the non-clinical studies, in the clinical trials, and in typical batches manufactured by the proposed commercial process. The QOS should state how the proposed impurity limits are qualified.
Bulk Drug Substance | legal definition of Bulk Drug Substance by L…
"Bulk drug substance" means any substance that is represented for use, and that, when used in the compounding, manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug; however, "bulk drug substance" shall not include intermediates that are used in the synthesis of such substances.
[DOC File]Department of Veterans Affairs, Controlled Substances ...
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1.2 Definition. For the purpose of this policy, a "drug" means any substance which is intended to be used in human beings or animals for diagnosis, treatment, cure, mitigation and prevention of diseases or for promotion of health or for the destruction of micro-organisms which have caused disease or to affect the physical structure or function ...
[DOCX File]INTRODUCTION - WHO | World Health Organization
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11. "Drug dependent person" means a person who is using a substance that is listed in paragraph 6, 19, 20, 21 or 28 of this section and who is in a state of psychological or physical dependence, or both, arising from the use of that substance. 12. "Federal act" has the same meaning prescribed in section 321901. 13.
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