GeneTherica / Analytical Documentation

Clascoterone — Certificate of Analysis

Batch-level analytical release documentation for research-grade Clascoterone raw material.

GeneTherica Certificate Documentation

Quality Status

Batch Conforming

Product Name

Clascoterone

Manufacturing Date

2025-10-11

Chemical Name

Cortexolone 17α-propionate

Analysis Date

2025-10-13

CAS Number

19608-29-8

Retest Date

2027-10-11

Molecular Formula

C24H34O5

Storage Conditions

Store in a cool, dry place below 25°C. Protect from light and moisture.

Molecular Weight

402.52 g/mol

Batch Number

GT-CL251011

Test

Specification

Result

Method

Status

Appearance

White to off-white crystalline powder

White crystalline powder

Visual

Pass

Identification

Conforms to reference standard

Complies

HPLC

Pass

Assay (Purity)

98.0% – 102.0%

99.60%

HPLC

Pass

Related Substances

≤ 1.50%

0.40%

HPLC

Pass

Single Unknown Impurity

≤ 0.20%

0.08%

HPLC

Pass

Water Content

≤ 0.50%

0.10%

Karl Fischer

Pass

Residual Solvents (Class I)

Not detected

Pass

Residual Ethanol

≤ 5000 ppm

286 ppm

Pass

Heavy Metals

≤ 10 ppm

< 10 ppm

ICP-MS

Pass

Arsenic (As)

≤ 2 ppm

< 0.5 ppm

ICP-MS

Pass

Lead (Pb)

≤ 1 ppm

< 0.5 ppm

ICP-MS

Pass

Cadmium (Cd)

≤ 1 ppm

< 0.2 ppm

ICP-MS

Pass

Mercury (Hg)

≤ 1 ppm

< 0.1 ppm

ICP-MS

Pass

Loss on Drying

≤ 0.50%

0.10%

USP

Pass

Residue on Ignition

≤ 0.20%

0.01%

USP

Pass

Conclusion

This batch complies with internal quality specifications for research-grade Clascoterone raw material.

Quality Standard

Internal Research Material Specification

Intended Use

Research purposes only

Packaging

Double-sealed light-protective packaging

Country of Manufacture

China

Distributed By

GeneTherica

Document Type

Analytical Release Documentation

Documentation Notice

This Certificate of Analysis is presented as analytical documentation for research-grade Clascoterone raw material associated with batch GT-CL251011. Values represent batch-level analytical testing and specification reference within a controlled non-clinical research documentation context.