ARMOR PHARMA lactose monohydrate 80M - 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

Applications & Uses

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)	0 - 20	%	Air Jet Sieve
Particle Size Distribution (max. 400 µm)	98 - 100	%	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 (%)

% < 100 µm ≤ 20

% < 400 µm 98 - 100

Sieving process gives coarse particles with a narrow particle size distribution enabling very good flowability.

PSD (Malvern Laser Diffraction, Indicative Values)
X₁₀ : 129 µm, X₅₀ : 256 µm, X₉₀ : 450 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: According to flowability index measured by Flodex, ARMOR PHARMA TM lactose monohydrate 80M exhibits a “very good” flowability.

Poured Density : 0.78 g/mL

Tapped Density : 0.87 g/mL

Carr’s Index : 10 %

Hausner Ratio : 1.11
Scanning Electron Microscopy
Process Flow Chart
Product Performance Characteristics: 1 2 3 4 5

Compressibility Very low Low Good High Very high

Flowability (Carr’s index) More than 26 21 to 25 16 to 20 11 to 15 0 to 10

Cohesiveness (Hausner ratio) 1.00 to 1.11 1.12 to 1.18 1.19 to 1.25 1.26 to 1.34 ≥ 1.35

Poured density (g/ml) Less than 0.50 0.50 to 0.59 0.60 to 0.69 0.70 to 0.79 ≥ 0.80

X₅₀ 0 to 20 21 to 50 51 to 100 101 to 200 ≥ 200

Span (PSD)* Less than 1.0 1.0 to 1.4 1.5 to 1.9 2 to 2.4 ≥ 2.5

SSA (m²/g) ≤ 0.10 0.10 to 0.40 0.41 to 0.80 0.81 to 1.40 ≥ 1.41

* Span = (X90 - X10) / X50

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 80M