Adapalene

Application of Adapalene:
It stimulates cell division in the skin and reduces the production of keratin. It aids skin peeling and prevents the formation of acne lesions (comedones). The action of adapalene combats the changes that take place in acne.
Adapalene is used in the treatment of mild to moderate acne. It is best suited to dry and fair skin.
Adapalene Powder is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. Adapalene has actions similar to vitamin A (retinol).

Name: Adapalene
CAS: 106685-40-9
MF: C28H28O3
MW: 412.52
Chemical Properties: White Crystalline Solid
Assay: 99.5%
Usage: Retinoid selective for retinoic acid receptor (RAR) subtypes β and γ.
Packing: Foil bag

    CERTIFICATE OF ANALYSIS

Product name
Adapalene
CAS No.
106685-40-9
Outer Packing
1kg/foil bag
Production date
2016.09.01
Shelf life
3 years
Standard adopted
EP7.410
Items of analysis
Specification
Results
Appearance
White to off white crystalline powder
White crystalline powder
Identification
IR spectrum exhibit maxim at the same wave numbers as the reference standard spectrum
Complies
.
HPLC spectrum exhibit maxim at the same wave numbers as the reference standard spectrum
Complies
Tetrahydrofuran 720ppm max
Acetic acid 5000ppm max
Not detected
Not detected
Methano 3000ppm max
Dichloromethane 600ppm max
Not detected
Not detected
N,N-Dimethyl formamide 880ppm max
Not detected
heavy metal
10ppm max
Complies
loss on drying
0.5% max
0.25%
sulphated ash
0.1% max
0.06%
related substance
Impurity A:0.3% max
Impurity D:0.2% max
Not detected
Not detected
Impurity C:0.15% max
Max unknown impurity:0.1% max
Not detected
Not detected
Total impurity:0.5% max
Not detected
Appearence of solution
Solution must clear and NMT BY6 of EP
Complies
solubility
Sparingly soluble in tetrahydrofuran,Pratically insolule in water and ethanol
Complies
Assay
98.0%- 102.0%
99.5%
Conclusion
Qualified

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