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PHR1084

Metformin hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

1,1-Dimethylbiguanide hydrochloride, Metformin

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500 MG

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About This Item

Linear Formula:
NH2C(=NH)NHC(=NH)N(CH3)2 · HCl
CAS Number:
1115-70-4
Molecular Weight:
165.62
NACRES:
NA.24
PubChem Substance ID:
329823106
UNSPSC Code:
41116107
EC Number:
214-230-6
MDL number:
MFCD00012582

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InChI key

OETHQSJEHLVLGH-UHFFFAOYSA-N

InChI

1S/C4H11N5.ClH/c1-9(2)4(7)8-3(5)6;/h1-2H3,(H5,5,6,7,8);1H

SMILES string

Cl[H].CN(C)C(=N)NC(N)=N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. M0605000, traceable to USP 1396309

API family

metformin

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

mp

223-226 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

Gene Information

—

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1 of 4

This Item
1396309BP227M-072
Metformin hydrochloride Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1084

Metformin hydrochloride

Metformin hydrochloride United States Pharmacopeia (USP) Reference Standard

USP

1396309

Metformin hydrochloride

Metformin hydrochloride British Pharmacopoeia (BP) Reference Standard

BP227

Metformin hydrochloride

Metformin hydrochloride solution 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material, Cerilliant®

Supelco

M-072

Metformin hydrochloride solution

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical
pharmaceutical small molecule

application(s)

pharmaceutical (small molecule)

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

gas chromatography (GC): suitable, liquid chromatography (LC): suitable

format

neat

format

neat

format

neat

format

single component solution

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

certified reference material

storage temp.

2-8°C

storage temp.

-

storage temp.

2-8°C

storage temp.

−20°C

General description

Metformin is a biguanide hypoglycaemic agent[1] and an oral antidiabetic medication[2] widely used in the treatment of type 2 diabetes.[3] It is effective in glycemic control and decreases the intestinal absorption of glucose,[1] without the problem of serious lactic acidosis.[3]
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

Metformin hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[1][2] using different chromatography techniques.
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

Metformin is an antidiabetic agent that reduces blood glucose levels and improves insulin sensitivity. Its metabolic effects, including the inhibition of hepatic gluconeogenesis, are mediated at least in part by activation of the LKB1-AMPK (AMP-activated protein kinase) pathway. Activation of this pathway also appears to be involved in the antiproliferative and proapoptotic actions of metformin in cancer cell lines.

Analysis Note

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

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
For chromatography information for this material, please follow the link:https://www.sigmaaldrich.com/US/en/technical-documents/chromatograms/hplc/hplc-dad-analysis-of-metformin-hydrochloride-on-ascentis-express-c18-hplc-column/supelco/app788
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.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

wgk

WGK 3

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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Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms
Lakshmi SK, et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 1(2), 162-166 (2009)
Simultaneous estimation of metformin hydrochloride and pioglitazone hydrochloride by RPHPLC method from combined tablet dosage form
Sahoo KP, et al.
Indian Journal of Pharmaceutical Sciences, 70(3), 383-383 (2008)
Stability-indicating HPTLC method for simultaneous determination of nateglinide and metformin hydrochloride in pharmaceutical dosage form
Thomas BA, et al.
Saudi Pharmaceutical Journal : SPJ : The Official Publication of the Saudi Pharmaceutical Society, 19(4), 221-231 (2011)
Leyuan Li et al.
Nature communications, 10(1), 4146-4146 (2019-09-14)
In vitro gut microbiome models could provide timely and cost-efficient solutions to study microbiome responses to drugs. For this purpose, in vitro models that maintain the functional and compositional profiles of in vivo gut microbiomes would be extremely valuable. Here
Nicolas Musi et al.
Diabetes, 51(7), 2074-2081 (2002-06-28)
Metformin is an effective hypoglycemic drug that lowers blood glucose concentrations by decreasing hepatic glucose production and increasing glucose disposal in skeletal muscle; however, the molecular site of metformin action is not well understood. AMP-activated protein kinase (AMPK) activity increases
View All Related Papers

Questions

1–3 of 3 Questions  

  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer

    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf

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  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer

    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

      Helpful?

  3. If I dilute with DI and filtrate with 0.2 micron sterile filter. How many month would you like to recommend, if I'll store at -80 degree Celsius? 

    1 answer

    1. The solution stability of this material has not been determined. Commercially available therapeutic solutions, containing potassium bicarbonate and xylitol, have a shelf life of approximately 2 years at controlled room temperature. A brief search of the literature revealed one study that suggests solutions at pH 2.5 - 8.2 are stable for 6 days at ambient temperature. Please see the link below to review this information:
      https://www.sciencedirect.com/science/article/abs/pii/S0099542808607571

      Unfortunately, no information regarding freezer storage or the freeze/thaw impact of this compound is available.

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