Product name: 4-Amino-2-Methylpentane Citrate

Item

Standard

Result

Method

Description

White crystalline powder

White crystalline powder

Organoleptic

Moisture Content

NMT 0.50% w/w

0.12% w/w

Karl Fischer

Melting Range

135°C - 139°C

135.2°C – 135.9°C

MPA

Color & Clarity of Solution

Solution must be clear and colorless solution

Passes

Visual

pH

3.0 – 4.0

3.7

USP

Heavy Metals

NMT 20 ppm

NMT 20 ppm

ICP-MS

Residue on Ignition

NMT 0.1% w/w

0.05% w/w

USP

Assay (Non Aq. Titration)

On dried basis

98.0% w/w – 101.0% w/w

99.78% w/w

Non Aqueous Titration

Total Aerobic Microbial Count

NMT 103 cfu/g

20 cfu/g

AACL-SAM 12008

E. Coli

Must be absent

Absent

AACL-SAM 12009

Salmonella

Must be absent

Absent

AACL-SAM 12012

Yeast & Mold

NMT 102 cfu/g

Absent

AACL-SAM 12010

Conclusion: The above results meet the factory standard