M-195

Metformin Impurity Mixture hydrochloride solution

50 μg/mL in methanol (each component), certified reference material, ampule of 1 mL, Cerilliant^®

• UNSPSC Code: 12352200

Properties

• grade: certified reference material
• form: liquid
• feature: Snap-N-Spike^®/Snap-N-Shoot^®
• packaging: ampule of 1 mL
• manufacturer/tradename: Cerilliant^®
• concentration: 50 μg/mL in methanol (each component)
• technique(s): gas chromatography (GC): suitable; liquid chromatography (LC): suitable
• application(s): pharmaceutical (small molecule)
• format: multi-component solution
• storage temp.: −20°C

Description

General description

Metformin, marketed under the trade name Glucophage among others, is a first-line medication for the treatment of type 2 diabetes and polycystic ovary syndrome. This solution mix Certified Reference Material contains metformin along with multiple impurities produced during pharmaceutical manufacturing of metformin - 1-methylbiguanide HCl (Metformin Related Compound B); melamine; and N,N-Dimethyl-1,3,5-triazine-2,4,6-triamine (Metformin Related Compound C). Used with M-196-1ML Cyanoguanidine (Metformin Related Compound A), this certified solution standard is suitable for use in metformin monograph testing methods by HPLC in testing applications ranging from API release testing to pharmaceutical research.

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.

Legal Information

CERILLIANT is a registered trademark of Merck KGaA, Darmstadt, Germany

Snap-N-Shoot is a registered trademark of Cerilliant Corporation

Snap-N-Spike is a registered trademark of Merck KGaA, Darmstadt, Germany

Analyte

Metformin Related Compound B, Pharmaceutical Secondary Standard; Certified Reference Material
Metformin Related Compound C, Pharmaceutical Secondary Standard; Certified Reference Material
Melamine, Pharmaceutical Secondary Standard; Certified Reference Material
Metformin hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

Safety Information

• pictograms: GHS02,GHS06,GHS08
• signalword: Danger
• hcodes: H225,H301 + H311 + H331,H370
• pcodes: P210 - P233 - P280 - P301 + P310 - P303 + P361 + P353 - P304 + P340 + P311
• Hazard Classifications: Acute Tox. 3 Dermal - Acute Tox. 3 Inhalation - Acute Tox. 3 Oral - Flam. Liq. 2 - STOT SE 1
• target_organs: Eyes,Central nervous system
• Storage Class: 3 - Flammable liquids
• wgk_germany: WGK 2
• flash_point_f: 49.5 °F - closed cup
• flash_point_c: 9.7 °C - closed cup