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Standards Impurities & Metabolites
Pharmaceutical Reference Standards / Green Standards Food And Beverage Standards / Agro-Chemical Standards / Environmental Standards

https://en.wikipedia.org/wiki/Pharmaceutical_formulation
https://en.wikipedia.org/wiki/Drug_reference_standard
https://www.ich.org/products/guidelines/quality/quality-single/article/impurities-in-new-drug-substances.html
https://en.wikipedia.org/wiki/Metabolomics
 


Packages of medication 
Other names : medicine, drug, pharmaceutical, pharmaceutical preparation, pharmaceutical product, medicinal product, medicament, remedy.

Drug reference standard

1. Definition
A pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.

2. Pharmacopoeial Reference standards
Pharmacopoeial Reference standards are a subset of Pharmaceutical Reference Standards. They are established for the intended use described in Pharmacopeial texts (monographs and general chapters). Pharmacopeial Reference Standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where pharmacopoeial tests or assays call for the use of a Pharmacopoeial Reference Standard, only those results obtained using the specified Pharmacopoeial Reference Standard are conclusive.


Impurities in new drug substances are addressed from two perspectives: Chemistry Aspects include classification and identification of impurities, report generation, listing of impurities in specifications, and a brief discussion of analytical procedures; and Safety Aspects include specific guidance for qualifying those impurities that were not present, or were present at substantially lower levels, in batches of a new drug substance used in safety and clinical studies.
Classification of impurities : Impurities can be classified into the following categories:
• Organic impurities (process- and drug-related)
 • Inorganic impurities
• Residual solvents

Organic impurities can arise during the manufacturing process and/or storage of the new drug substance. They can be identified or unidentified, volatile or non-volatile, and include:
• Starting materials
• By-products
• Intermediates
• Degradation products
• Reagents, ligands and catalysts

Inorganic impurities can result from the manufacturing process. They are normally known and identified and include:
• Reagents, ligands and catalysts
• Heavy metals or other residual metals
• Inorganic salts
• Other materials (e.g., filter aids, charcoal)          

Free metabolites for an E. coli cell growing on glucose.
metabolite is the intermediate end product of metabolism. The term metabolite is usually restricted to small molecules. Metabolites have various functions, including fuel, structure, signaling, stimulatory and inhibitory effects on enzymes, catalytic activity of their own (usually as a cofactor to an enzyme), defense, and interactions with other organisms (e.g. pigmentsodorants, and pheromones). A primary metabolite is directly involved in normal "growth", development, and reproduction. Ethylene is an example of a primary metabolite produced in large-scale by industrial microbiology. A secondary metabolite is not directly involved in those processes, but usually has an important ecological function. Examples include antibiotics and pigments such as resins and terpenes etc. Some antibiotics use primary metabolites as precursors, such as actinomycin which is created from the primary metabolite, tryptophan. Some sugars are metabolites, such as fructose or glucose, which are both present in the metabolic pathways.
Class Example
Alcohol Ethanol
Amino acids Glutamic acid, aspartic acid
Nucleotides 5' guanylic acid
Antioxidants Isoascorbic acid
Organic acids Acetic acid, lactic acid
Polyols Glycerol
Vitamins B2

The metabolome forms a large network of metabolic reactions, where outputs from one enzymatic chemical reaction are inputs to other chemical reactions.

Metabolites from chemical compounds, whether inherent or pharmaceutical, are formed as part of the natural biochemical process of degrading and eliminating the compounds.[2] The rate of degradation of a compound is an important determinant of the duration and intensity of its action. Profiling metabolites of pharmaceutical compounds, drug metabolism, is an important part of drug discovery, leading to an understanding of any undesirable side effects.


Examples of primary metabolites produced by industrial microbiology:[1]

 

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With state of art research & development centers, advanced equipments, modern facilities and well blending and highly experienced competent scientists and experts and dynamic team of associates, Pharmaffiliates, since 2001, has been focusing mainly on synthetic, analytical researches, NDDS and regulatory consulting and certified processes to pump bio-pharmaceutical development pipeline with highest quality, efficiency and cost advantages !
We regularly prepare stock or synthesis by request the following branches of materials:

  • Pharmaceutical Reference Standards
  • Impurities & Metabolites Standards
  •  Pharmaceutical Material Standards
  • Green Standards
  • Food And Beverage Standards
  • Agro-Chemical Standards Environmental Standards

Our Synthetic Service includes most categories of customized compounds :

  • Deuterium Compounds
  • Non Pharmaceutical Standards
  • Phyto-Chemical Standards
  • Petrochemical Standards
  • Pesticides Standards
  • Food and Beverage Standards
  • Environmental Standards
  • Agro-Chemical Standards

Our team puts great emphasis on first-class quality. We feel obliged to satisfy the highest demands, one of the keys to the success of Pharmaffiliates.

Pharmaceutical Reference Standards
Pharmaceutical Ingredients

Green Standards
Pharmaceutical Ingredients

Food And Beverage Standards
Pharmaceutical Ingredients

Agro-Chemical Standards
Pharmaceutical Ingredients

Environmental Standards
Pharmaceutical Ingredients

List of Impurities & Metabolites

 

Product

Code

 

Product/Chemical Name

Product Group/C ategory

 

Synonyms

 

Unit Size

Storage Condition s

 

CAS No.

 

Molecular

Weight

 

Molecular

Formula

 

Other Details

 

Other Details 1

 

 

 

PA 01 01000

 

 

 

Abacavir

 

 

 

API

 

 

(1S,4R)-4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-methanol;

 

 

 

25MG,50MG

 

 

 

Refrigerator

 

 

 

136470-78-5

 

 

 

286.33

 

 

 

C14H18N6O

 

 

(1S-cis)-4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-

2-cyclopentene-1-methanol;

1592U89; ABC;

 

 

 

Abacavir - API

 

 

PA 01 01510

 

 

Descyclopropyl Abacavir

 

 

IH

 

 

(1S,4R)-4-(2,6-Diamino-9H-purin-9-yl)-2- cyclopentene-1-methanol;

 

 

25MG,50MG

 

 

Freezer

 

 

124752-25-6

 

 

246.27

 

 

C11H14N6O

 

 

Abacavir Related Compound A;

 

 

Abacavir - In house impurity

 

 

PA 01 01520

 

 

(1S,4R)-4-(2-Amino-6-chloro-9H-purin-9- yl)-2-cyclopentene-1-methanol Hydrochloride

 

 

IH

 

 

(1S-cis)-4-(2-Amino-6-chloro-9H-purin-9- yl)-2-cyclopentene-1-methanol Monohydrochloride;

 

 

25MG,50MG

 

 

Refrigerator, Under Inert Atmosphere

 

 

172015-79-1

 

 

302.16

 

 

C11H13Cl2N5O

 

 

Abacavir Related Compound C;

 

 

Abacavir - In house impurity

 

 

 

PA 01 01530

 

 

 

trans-Abacavir Hydrochloride

 

 

 

IH

 

 

(1R,4R)-rel-4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-methanol Hydrochloride;

 

 

 

25MG,50MG

 

 

 

NA

 

 

 

267668-71-3

 

 

 

322.79

 

 

 

C14H19ClN6O

 

 

 

NA

 

 

 

Abacavir - In house impurity

 

 

 

PA 01 01540

 

 

 

Abacavir Sulfate

 

 

 

IH

 

 

(1S,4R)-4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-methanol Sulfate; Ziagen;

 

 

 

25MG,50MG

 

 

 

Freezer

 

 

 

188062-50-2

 

 

 

670.47

 

 

 

C28H38N12O6S

 

 

 

NA

 

 

 

Abacavir - In house impurity

 

 

 

PA 01 01550

 

 

 

Abacavir Carboxylate

 

 

 

IH

 

 

(1S,4R)-4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-carboxylic Acid; 2269W;

 

 

 

25MG,50MG

 

 

Hygroscopic, Freezer, Under Inert Atmosphere

 

 

 

384380-52-3

 

 

 

300.32

 

 

 

C14H16N6O2

 

 

 

NA

 

 

Abacavir - In house impurity

 

 

 

PA 01 01560

 

 

 

Abacavir 5-β-D-Glucuronide

 

 

 

IH

 

[(1S,4R)-4-[2-amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopenten-1-yl]methyl-β-D- Glucopyranosiduronic Acid; Abacavir 5- Glucuronide;

 

 

 

25MG,50MG

 

 

Freezer, Under Inert Atmosphere

 

 

 

384329-76-4

 

 

 

462.46

 

 

 

C20H26N6O7

 

 

 

NA

 

 

Abacavir - In house impurity

 

 

 

PA 01 01570

 

 

 

Abacavir 5-Phosphate

 

 

 

IH

 

 

(1S,4R)- 4-[2-Amino-6- (cyclopropylamino)-9H-purin-9-yl]-2- cyclopentene-1-methanol Dihydrogen Phosphate (Ester);

 

 

 

25MG,50MG

 

 

 

Freezer

 

 

 

136470-77-4

 

 

 

366.31

 

 

 

C14H19N6O4P

 

 

 

(1S-cis)-Abacavir Monophosphate;

 

 

 

Abacavir - In house impurity


P1 - P977 - List_Impurities & Metabolites.pdf

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