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- Posts: 1
- Joined: Tue Jul 04, 2023 10:47 am
- Location: India
Dear Friends
This query regarding Carbocisteine oral solution related substance method.
L-Tyrosine NMT 0.2%
L-Cysteine NMT 0.3%
Carbocisteine Lactum NMT 0.2%
Carbocisteine Sulfoxide NMT 0.3%
Above are the limits . Carbocisteine Lactum & Carbocisteine Sulfoxide are the degradant impurity which increase & failing in 1M 40/75 & 30/75 stability conditions.
How to justify these limits or any experience with this products.
This query regarding Carbocisteine oral solution related substance method.
L-Tyrosine NMT 0.2%
L-Cysteine NMT 0.3%
Carbocisteine Lactum NMT 0.2%
Carbocisteine Sulfoxide NMT 0.3%
Above are the limits . Carbocisteine Lactum & Carbocisteine Sulfoxide are the degradant impurity which increase & failing in 1M 40/75 & 30/75 stability conditions.
How to justify these limits or any experience with this products.
