1.08195

Lactose monohydrate

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

• Sinonimo/i: Lactose monohydrate, Milk sugar, Lactobiose
• Formula empirica (notazione di Hill): C₁₂H₂₂O₁₁ · xH₂O
• Numero CAS: 10039-26-6
• Peso molecolare: 342.30 (anhydrous basis)
• Codice UNSPSC: 12352201
• Numero indice EU: 200-559-2

Proprietà

• agenzia: BP; ChP; JP; NF; Ph. Eur.
• Livello qualitativo: 500
• Nome Commerciale: EMPROVE^® ESSENTIAL
• Forma fisica: fine powder
• Temp. autoaccensione: 390 °C
• Potenza: >10000 mg/kg LD₅₀, oral (Rat)
• Dimensione particelle: (see specification)
• pH: 4.0-6.5 (20 °C, 100 g/L in H₂O)
• Punto di fusione: 202 °C
• applicazioni: liquid formulation; pharmaceutical; semi-solid formulation; solid formulation
• Temperatura di conservazione: 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; GUBGYTABKSRVRQ-XLOQQCSPSA-N

Descrizione

Descrizione generale

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.

Applicazioni

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

Note legali

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

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

Informazioni sulla sicurezza

• Codice della classe di stoccaggio: 11 - Combustible Solids
• Classe di pericolosità dell'acqua (WGK): WGK 2
• Punto d’infiammabilità (°F): Not applicable
• Punto d’infiammabilità (°C): Not applicable