PHARMATOSE 350M

PHARMATOSE 350 M is a white or almost white, crystalline powder freely soluble in water, practically insoluble in ethanol. PHARMATOSE 350 M conforms to USP - NF, Ph.Eur., JP Lactose monohydrate monograph, current at time of manufacture. It has a specification of water content between 4.5-5.5 % and loss on drying maximum of 0.5 %. PHARMATOSE 350 M provides benefits for pharmaceutical applications due to its specific optical rotation: [a]20 D, anhydrous basis +54.4° to +55.9° and residue on ignition/Sulphated ash maximum of 0.10%. Its proteins and light absorbing impurities [A] 1%, 1 cm at 270 - 300 nm maximum of 0.07 [A] 1%, 1 cm at 210 - 220 nm maximum of 0.25 make it suitable for use in tablets, capsules and other solid dosage forms. PHARMATOSE 350 M conforms to strict manufacturing standards with a total aerobic microbial count maximum of 100 cfu/g and yeasts/moulds maximum 10 cfu/g, ensuring safety and stability for use in pharmaceutical products.