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PHR1084

Supelco

二甲双胍 盐酸盐

Pharmaceutical Secondary Standard; Certified Reference Material

同義詞:

1,1-二甲双胍 盐酸盐, 盐酸二甲双胍

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About This Item

線性公式:
NH2C(=NH)NHC(=NH)N(CH3)2 · HCl
CAS號碼:
1115-70-4
分子量：:
165.62
EC號碼:
214-230-6
MDL號碼:
MFCD00012582
分類程式碼代碼:
41116107
PubChem物質ID:
329823106
NACRES:
NA.24
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等級

certified reference material
pharmaceutical secondary standard

品質等級

300

agency

traceable to Ph. Eur. M0605000
traceable to USP 1396309

API 家族

metformin

CofA

current certificate can be downloaded

包裝

pkg of 500 mg

技術

HPLC: suitable
gas chromatography (GC): suitable

mp

223-226 °C (lit.)

應用

pharmaceutical (small molecule)

形式

neat

儲存溫度

2-8°C

SMILES 字串

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

InChI

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

InChI 密鑰

OETHQSJEHLVLGH-UHFFFAOYSA-N

基因資訊

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相關類別

一般說明

二甲双胍是一种双胍类降血糖药[1]，是一种广泛用于治疗II型糖尿病的口服降糖药[2]。[3]它可有效控制血糖，并减少肠道对葡萄糖的吸收[1]，且不存在重度乳酸性酸中毒问题。[3]
用于质量控制的制药二级标准品，为制药实验室和制造商制备内部工作标准品提供了一种方便、高性价比的替代方案。

應用

盐酸二甲双胍可用作制药参考标准品，通过不同的色谱技术定量药物制剂中的分析物[1][2]。
这些二级标准品是经认证过的有证标准物质（CRM）。它们适用于多种分析应用，包括但不限于药物释放测试、药物的定性和定量分析方法开发、食品和饮料质量控制检测以及其他校准需求。

生化／生理作用

二甲双胍是一种降糖药，可以降低血糖水平，提高胰岛素敏感性。 它的代谢作用，包括抑制肝脏糖异生，至少部分是通过激活LKB1-AMPK（AMP活化蛋白激酶）通路介导的。 这一通路的激活也参与了二甲双胍在癌细胞系中的抗增殖和促凋亡作用。

分析報告

这些二级标准为USP、EP（PhEur）和BP 主要标准提供了多种可追溯性。

其他說明

该认证参考物质（CRM）根据ISO 17034 和 ISO/IEC 17025进行生产和认证。有关此CRM使用的所有信息均可在分析证书上找到。

腳註

如需该物质的色谱信息，请点链接：https://www.sigmaaldrich.com/US/en/technical-documents/chromatograms/hplc/hplc-dad-analysis-of-metformin-hydrochloride-on-ascentis-express-c18-hplc-column/supelco/app788

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象形圖

Exclamation mark
GHS07

訊號詞

Warning

危險聲明

H302

危險分類

Acute Tox. 4 Oral

儲存類別代碼

11 - Combustible Solids

水污染物質分類（WGK）

WGK 3

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分析證明 (COA)

Lot/Batch Number

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存取文件庫

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)
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)
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
Thomas Meul et al.
Cell reports, 32(8), 108059-108059 (2020-08-28)
The proteasome is the main proteolytic system for targeted protein degradation in the cell and is fine-tuned according to cellular needs. Here, we demonstrate that mitochondrial dysfunction and concomitant metabolic reprogramming of the tricarboxylic acid (TCA) cycle reduce the assembly
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  1. 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

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  2. 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/449/386/product-dating-information-mk.pdf

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  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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