Download our Methods of analysis

ARMOR PHARMA™ main objective is to ensure quality, sustainability and safety so as to comply with the most stringent regulatory requirements. Our Quality and Regulatory Affairs Departments work closely together to stay up-to-date on all regulatory changes. 

This "Quality and regulatory corner" is intended to :

- facilitate your access to the latest versions of our quality documents

- provide you with all necessary information for carrying out your product risk assessment,

- enable you finding your CoAs

Note : Regulatory and quality documents are available to registered users.

LACTOSE
MONOHYDRATE


Free flowing and highly compressible powders for wet/dry granulation, capsules and sachets manufacturing.

EXCIPRESS™


Granulated and Spray dried lactose for Direct Compression, combining high compressibility & flowability.

EXCIPURE™


A range of lactose grades from coarse crystals to fine powders for Dry Powder Inhalers.
TEST TEST LIMITS METHOD OF ANALYSIS
AppearanceWhite crystalline powderConnect to download
SolubilityFreely soluble in waterConnect to download
Infrared absorption spectophotometrySpectrum similar to CRS spectrumConnect to download
Water4.5% to 5.5%Connect to download
Appearance of solutionClear and not more intensely coloured than BY7Connect to download
Acidity or alkalinity≤ 0,4 ml NaOH 0,1MConnect to download
Specific optical rotation+54,4 to +55,9 (anhydrous substance)Connect to download
Absorbance: proteins and light-absorbing impurities[A] 1% 1cm at 210 to 220 nm max 0.25 [A] 1% 1cm at 270 to 300 nm max 0.07 [A] 1% 1cm at 400 nm max 0.04Connect to download
Heavy metalsmax. 5 ppmConnect to download
Water4.5% to 5.5%Connect to download
Residue on igniton/Sulphated Ashmax 0.1%Connect to download
Loss on dryingmax 0.5%Connect to download
Particle Size Distribution 80MConnect to download
Particle Size Distribution 150MConnect to download
Particle Size Distribution 200MConnect to download
Particle Size Distribution 350MConnect to download
Particle Size Distribution 450MConnect to download
Total aerobic microbial count (TAMC)max 100 CFU/gConnect to download
Total yeast and moulds count (TYMC)max 50 CFU/gConnect to download
Escherichia Colineg. In 1 gConnect to download
Salmonellaneg. In 10 gConnect to download
TEST TEST LIMITS METHOD OF ANALYSIS
AppearanceWhite crystalline powderConnect to download
SolubilityFreely soluble in waterConnect to download
Infrared absorption spectophotometrySpectrum similar to CRS spectrumConnect to download
Water4.5% to 5.5%Connect to download
Appearance of solutionClear and not more intensely coloured than BY7Connect to download
Acidity or alkalinity≤ 0,4 ml NaOH 0,1MConnect to download
Specific optical rotation +54,4 to +55,9 (anhydrous substance)Connect to download
Absorbance: proteins and light-absorbing impurities[A] 1% 1cm at 210 to 220 nm max 0.25 [A] 1% 1cm at 270 to 300 nm max 0.07 [A] 1% 1cm at 400 nm max 0.04Connect to download
Heavy metalsmax. 5 ppmConnect to download
Water4.5% to 5.5%Connect to download
Residue on igniton/Sulphated Ashmax 0.1%Connect to download
Loss on dryingmax 0.5%Connect to download
Particle Size Distribution GR150Connect to download
Particle Size Distribution SD2Connect to download
Total aerobic microbial count (TAMC)max 100 CFU/gConnect to download
Total yeast and moulds count (TYMC)max 50 CFU/gConnect to download
Escherichia Colineg. In 1 gConnect to download
Salmonellaneg. In 10 gConnect to download
TEST TEST LIMITS METHOD OF ANALYSIS
AppearanceWhite crystalline powderConnect to download
SolubilityFreely soluble in waterConnect to download
Infrared absorption spectophotometrySpectrum similar to CRS spectrumConnect to download
Water4.5% to 5.5%Connect to download
Purity (HPLC)>99,7%Connect to download
Water4.5% to 5.5%Connect to download
Loss on dryingmax 0.5%Connect to download
Specific optical rotation+54,4 to +55,9 (anhydrous substance)Connect to download
Sulphated Ashmax 0.1%Connect to download
Absorbance: proteins and light-absorbing impurities[A] 1% 1cm at 210 to 220 nm max 0.25 [A] 1% 1cm at 270 to 300 nm max 0.07 [A] 1% 1cm at 400 nm max 0.04Connect to download
Appearance of solutionClear and not more intensely coloured than BY7Connect to download
Acidity or alkalinity≤ 0,4 ml NaOH 0,1MConnect to download
Heavy metalsmax. 5 ppmConnect to download
Total aerobic microbial count (TAMC)max 10 CFU/gConnect to download
Total yeast and moulds count (TYMC)max 10 CFU/gConnect to download
Escherichia Colineg. in 10 gConnect to download
Salmonellaneg. in 10 gConnect to download
Bile tolerant gram negative bacteriaAbsence/ 10 gConnect to download
Staphylococcus aureusAbsence/ 10 gConnect to download
Pseudomonas aeruginosaAbsence/ 10 gConnect to download
Burkholderia cepaciaAbsence/ 10 gConnect to download
Endotoxins≤5 EU/gConnect to download