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PHR1331

Metformin Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Dicyandiamide, Cyanoguanidine, Dicyanodiamide

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About This Item

Linear Formula:
NH2C(=NH)NHCN
CAS Number:
Molecular Weight:
84.08
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
207-312-8
Beilstein/REAXYS Number:
605637
MDL number:
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Quality Level

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to USP 1396310

API family

metformin

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

mp

208-211 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

NC(=N)NC#N

InChI

1S/C2H4N4/c3-1-6-2(4)5/h(H4,4,5,6)

InChI key

QGBSISYHAICWAH-UHFFFAOYSA-N

General description

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.

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.

It is an impurity of the widely used antidiabetic drug, metformin, that belongs to the biguanide class of compounds.

Application

This pharmaceutical secondary standard can also be used as follows:
  • Separation and estimation of metformin along with other antidiabetics from meglitinides class in the presence of metformin impurity cyanoguanidine using a liquid chromatography method in pharmaceutical formulations
  • Development of a reversed phase-high performance liquid chromatographic (RP-HPLC) method combined with a UV-diode array detector (PDA) for the impurity analysis of combined dosage tablet of metformin hydrochloride and teneligliptin hydrobromide hydrate
  • Estimation of empagliflozin, linagliptin, along with metformin and its related impurities cyanoguanidine and melamine using HPLC-DAD and high-performance thin layer chromatography (HPTLC) methods in their combined tablets
  • Development and validation of a stability indicating capillary zone electrophoresis (CZE) method for the quantification of metformin and its major impurity in pharmaceutical formulation
  • Simultaneous determination of vildagliptin, metformin, and metformin-related compounds (A, B, and C) in tablets using a high-performance liquid chromatography-tandem mass spectrometry method (HPLC-MS/MS)

Analysis Note

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

Other Notes

To see an example of a Certificate of Analysis for this material enter LRAA0834 in the slot below. This is an example certificate only and may not be the lot that you receive.


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Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable



Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Green chromatographic methods for simultaneous micro-determination of empagliflozin, linagliptin with metformin and its pharmacopoeial impurities in pure form and triple combination tablets: A comparative study
El-Kafrawy DS, et al.
Sustainable Chemistry and Pharmacy, 25, 100560-100560 (2022)
HPLC-MS/MS method for simultaneous quantification of vildagliptin, metformin, and metformin-related compounds in tablets
Uber CP, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 6, 203-207 (2014)
Peng Li et al.
Angewandte Chemie (International ed. in English), 54(2), 574-577 (2014-11-15)
Self-assembly of a trigonal building subunit with diaminotriazines (DAT) functional groups leads to a unique rod-packing 3D microporous hydrogen-bonded organic framework (HOF-3). This material shows permanent porosity and demonstrates highly selective separation of C2H2/CO2 at ambient temperature and pressure.



Global Trade Item Number

SKUGTIN
PHR1331-500MG04061835518418