ARMOR PHARMA lactose monohydrate 201 - Armor Pharma

Identification & Functionality

Chemical Name: Lactose Monohydrate
Pharma & Nutraceuticals Functions: Compression Aid
CAS No.: 10039-26-6
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Formulation & Processing Aids

Features & Benefits

Benefit Claims: Excellent Stability,
Good Blending Properties,
Good Compressibility,
Low Hygroscopicity
Key Benefits: Compressibility

Blending properties

Storage stability

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Tablets
Manufacturing Technology: Dry Granulation,
Wet Granulation
Applications: Wet granulation

Dry granulation

Blends Premixes /Triturations

Fermentation processes

Properties

	Value	Units	Test Method / Conditions
Absorbance (Proteins and Light Absorbing Impurities, [A] 1%, 1 cm at 210 to 220 nm)	max. 0.25	—	—
Absorbance (Proteins and Light Absorbing Impurities, [A] 1%, 1 cm at 270 to 300 nm)	max. 0.07	—	—
Absorbance (Proteins and Light Absorbing Impurities, [A] 10%, 1 cm at 400 nm)	max. 0.04	—	—
Acidity or Alkalinity (at ml 0.1 M NaOH)	max. 0.4	—	—
Escherichia Coli	Negative	in 1g	—
Heavy Metals	max. 5	ppm	USP
Loss on Drying	max. 0.5	%	—
Particle Size Distribution (max. 100 µm)	min. 90	%	Air Jet Sieve
Particle Size Distribution (max. 32 µm)	45 - 75	%	Air Jet Sieve
Residue on Ignition / Sulphated Ash	max. 0.1	%	—
Salmonella	Negative	in 10g	—
Specific Optical Rotation (at [α] 20D, Anhydrous Substance)	54.4 - 55.9	degree	—
Total Aerobic Microbial Count	max. 100	CFU/g	—
Total Yeast and Molds Count	max. 50	CFU/g	—
Water Content	4.5 - 5.5	%	KF Method

Regulatory & Compliance

Certifications & Compliance: EXCiPACT,
European Pharmacopeia (Ph. Eur.),
GMP,
ISO 22000,
ISO 9001,
Japan Pharmacopeia (JP),
National Formulary (NF),
United States Pharmacopeia (USP)
Grade: Pharma Grade
Residual Solvents: No class 1, 2, 3 solvents are used during production. (CPMP/ICH/283/95 + CVMP/VICH/502/99)
Certifications: EXCIPACT certified (GMP)

ISO 9001 and ISO 22000 certified

Following IPEC cGMP

On-site Batch testing & Batch release

Certified animal Rennet-free raw materials

Technical Details & Test Data

Particle Size Distribution: PSD
(Air Jet Sieve) Specifications (%)

% < 32 µm 45 - 75

% < 100 µm ≥ 90

Due to the presence of fine milled particles, this α lactose monohydrate combines good compaction and blending properties.

PSD (Malvern Laser Diffraction, Indicative Values)
X₁₀ : 6 µm, X₅₀ : 34 µm, X₉₀ : 98 µm
Moisture Sorption: The hygroscopicity of α lactose monohydrate is very low which enables high stability both in storage as well as in formulations

DVS (Dynamic Vapor Sorption)
Flowability: Poured Density : 0.50 g/mL

Tapped Density : 0.80 g/mL

Carr’s Index : 37 %

Hausner Ratio : 1.58
Scanning Electron Microscopy
Process Flow Chart

Packaging & Availability

Storage & Handling

Shelf Life: 36 Months
Storage Information: Store in original unopened packaging, in a dry and odor free place.

ARMOR PHARMA™ lactose monohydrate 201