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1.07656

SAFC

Lactose monohydrate

powder, EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, JP, NF

Pharma Manufacturing

Synonym(s):

Lactose monohydrate, Milk sugar, Lactobiose

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About This Item

CAS Number:
10039-26-6
Molecular Weight:
360.32
UNSPSC Code:
12352201
EC Index Number:
200-559-2

Agency

BP
ChP
JP
NF
Ph. Eur.

Quality Level

500

product line

EMPROVE® ESSENTIAL

form

fine powder
powder

autoignition temp.

390 °C

potency

>10000 mg/kg LD50, oral (Rat)

pH

4.0-6.5 (20 °C, 100 g/L in H2O)

mp

202 °C

solubility

161 g/L

application(s)

liquid formulation
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

15-25°C

InChI

1S/C12H22O11/c13-1-3-5(15)6(16)9(19)12(22-3)23-10-4(2-14)21-11(20)8(18)7(10)17/h3-20H,1-2H2/t3-,4-,5+,6+,7-,8-,9-,10-,11+,12+/m1/s1

InChI key

GUBGYTABKSRVRQ-XLOQQCSPSA-N

Related Categories

General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our EMPROVE® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Lactose is a commonly used ingredient in food and pharmaceutics. In pharmaceutical applications, lactose has been used primarily for solid oral dosage forms.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

WGK

WGK 2

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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