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Safety Information

1.08195

SAFC

Lactose monohydrate

(milk sugar) special grade for tabletting, EMPROVE® ESSENTIAL, Ph. Eur., BP, ChP, JP, NF

Pharma Manufacturing

Synonym(s):

Lactose monohydrate, Milk sugar, Lactobiose

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About This Item

Empirical Formula (Hill Notation):
C12H22O11 · xH2O
CAS Number:
10039-26-6
Molecular Weight:
342.30 (anhydrous basis)
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

autoignition temp.

390 °C

potency

>10000 mg/kg LD50, oral (Rat)

particle size

(see specification)

pH

4.0-6.5 (20 °C, 100 g/L in H2O)

mp

202 °C

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

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

1081959999:
MX11081959999:
CO1E1081959525:
EC11081959029:
1081959029BWT:
1081959525:
1081959029:
CO1E1081959029:
1081950000:

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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