Certificate of Analysis

Product name: Mometasone furoate

Number of analysis: T0002413

Batch number / Weight: 15H10-H02-00476 / 1g

Producer Batch Number: NU0698M

Analysed according to: PH.EUR 8.2

Tests Requirement Result Unit Standard remark

Appearance White or almost white powder Conform

Identification A Conform Conform IR-spectrum
Identification B Conform Conform TLC
Specific optical rotation +50 - +55 +50,21 ° Dried, 0,5%m/V EtOH(96%)
Related substances Conform Conform HPLC; DP
Impurity A <= 0,3 Conform %
Impurity B <= 0,3 Conform %
Impurity C <= 0,3 Conform %
Impurity D <= 0,3 Conform %
Impurity E <= 0,3 Conform %
Impurity F <= 0,3 Conform %
Impurity G <= 0,3 Conform %
Impurity H <= 0,3 Conform %
Impurity I <= 0,3 Conform %
Total impurities <= 0,6 Conform %
Loss on drying <= 0,5 0,21 % 105°C in an oven
Assay Mometasone furoate 97,0 - 103,0 99,7 %m/m Dried, UV, at 249nm
Particle size 100% < 20μm Conform DP
Particle size >= 90% < 10μm Conform DP
Residual solvents CPMP/ICH/283/95 Conform DP

Analysis performed by the authorized internal lab.

Release:
Vasileios Dimitroulis
Pharmacist - QA Manager / QP

11/08/2015

Expiration: 04-2019

Conclusion: APPROVED

This document has been produced electronically from our quality system and is valid without signature.