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Merck

PHR1025

Lactose, Anhydrous

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

Lactose

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Fórmula empírica (notación de Hill):
C12H22O11
Número CAS:
Peso molecular:
342.30
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
200-559-2
Beilstein/REAXYS Number:
93796
MDL number:
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Quality Level

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. A1206000, traceable to USP 1356676

API family

lactose

assay

99.9% (mass balance / as is basis)

CofA

current certificate can be downloaded

analyte chemical class(es)

oligosaccharides

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

cleaning products
cosmetics
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

OC[C@@H](O)[C@@H](O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O)[C@H](O)[C@@H](O)C=O

InChI

1S/C12H22O11/c13-1-4(16)7(18)11(5(17)2-14)23-12-10(21)9(20)8(19)6(3-15)22-12/h1,4-12,14-21H,2-3H2/t4-,5+,6+,7+,8-,9-,10+,11+,12-/m0/s1

InChI key

DKXNBNKWCZZMJT-JVCRWLNRSA-N

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.

Application

Lactose, Anhydrous may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by 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.

Analysis Note

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

Other Notes

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.
To see an example of a Certificate of Analysis for this material enter LRAB2931 in the slot below. This is an example certificate only and may not be the lot that you receive.


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Clase de almacenamiento

11 - Combustible Solids

flash_point_f

Not applicable

flash_point_c

Not applicable



Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Assessment of feasibility of Maillard reaction between baclofen and lactose by liquid chromatography and tandem mass spectrometry, application to pre formulation studies
Monajjemzadeh F, et al.
Aaps Pharmscitech, 10(2), 649-659 (2009)
The influence of carrier and drug morphology on drug delivery from dry powder formulations
Larhrib H, et al.
International Journal of Pharmaceutics, 257(1-2), 283-296 (2003)
Compatibility studies of acyclovir and lactose in physical mixtures and commercial tablets
Monajjemzadeh F, et al.
European Journal of Pharmaceutics and Biopharmaceutics, 73(3), 404-413 (2009)