1.08195

Lactose monohydrate

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

• Synonym(s): Lactose monohydrate, Milk sugar, Lactobiose
• 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

Properties

• 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

Description

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable