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Merck
CN

PHR1623

氢溴酸加兰他敏

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

加兰他敏氢溴酸盐 氢溴酸盐

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关于此项目

经验公式（希尔记法）:
C17H21NO3 · HBr
化学文摘社编号:
1953-04-4
分子量:
368.27
UNSPSC Code:
41116107
NACRES:
NA.24
EC Number:
217-780-5
MDL number:
MFCD26142877

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产品名称

氢溴酸加兰他敏, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

QORVDGQLPPAFRS-XPSHAMGMSA-N

InChI

1S/C17H21NO3.BrH/c1-18-8-7-17-6-5-12(19)9-14(17)21-16-13(20-2)4-3-11(10-18)15(16)17;/h3-6,12,14,19H,7-10H2,1-2H3;1H/t12-,14-,17-;/m0./s1

SMILES string

[H][C@]1(O2)C[C@@H](O)C=C[C@@]13C4=C2C(OC)=CC=C4CN(C)CC3.Br

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001279
traceable to USP 1287755

API family

galantamine

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

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相关类别

Other Notes

To see an example of a Certificate of Analysis for this material enter LRAC1681 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.
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.

Analysis Note

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

Application

Galantamine Hydrobromide may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various 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.

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.
Galantamine Hydrobromide, a reversible, competitive acetyl cholinesterase inhibitor, is suggested for the remedy of mild to moderate dementia of the Alzheimer′s type.

pictograms

Skull and crossbones
GHS06

signalword

Danger

hcodes

H301

Hazard Classifications

Acute Tox. 3 Oral

存储类别

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

法规信息

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Quantitative determination of galantamine hydrobromide in pharmaceutical dosage form by RP-high performance liquid chromatography.
Krupesh BP, et al.
Journal of Chemical and Pharmaceutical Research, 2(2), 36-43 (2010)
Improving method capability of a drug substance HPLC assay.
Dejaegher B, et al.
Journal of Pharmaceutical and Biomedical Analysis, 42(2), 155-170 (2006)
Pharmacokinetics and bioequivalence studies of galantamine hydrobromide dispersible tablet in healthy male Chinese volunteers.
Zhang LJ, et al.
Drug Development and Industrial Pharmacy, 33(3) (2007)
Oil-in-water microemulsion high performance liquid chromatographic analysis of pharmaceuticals.
Marsh A, et al.
Chromatographia, 59(9), 531-542 (2004)

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