PHR2356

Betaine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Betaine hydrochloride, (Carboxymethyl)trimethylammonium hydrochloride
• Linear Formula: (CH₃)₃N⁺CH₂COOH · Cl^-
• CAS Number: 590-46-5
• Molecular Weight: 153.61
• Beilstein: 3916181
• MDL number: MFCD00011903
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1065709
• API family: betaine
• form: powder
• CofA: current certificate can be downloaded
• packaging: pkg of 300 mg
• mp: 241-242 °C (lit.)
• application(s): pharmaceutical small molecule
• storage temp.: 2-30°C

Description

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

End-product of oxidative metabolism of choline, betaine is a general methyl donor, in particular in a minor pathway of methionine biosynthesis. It is used to treat homocystinuria, which is a defect in the major pathway of methionine biosynthesis.[1]

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC5296 in the documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS05
• Signal Word: Danger
• Hazard Statements: H318
• Precautionary Statements: P280 - P305 + P351 + P338
• Hazard Classifications: Eye Dam. 1
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable