PANTOPRAZOLE SODIUM IP
We are supplier and exporter of Pantoprazole Sodium IP / USP from GMP manufacturing facility in India. We supply this product at competitive price with good quality. It is white to off white powder. It is is a proton-pump inhibitor. Pantoprazole Sodium API / Powder – Supplier / Manufacturer
https://chynopspharma.com/apis/ – Go to Product Page
| Sr No | Tests | Specifications |
|---|---|---|
| 1 | Description | A white to off white powder |
| 2 | Identification | |
| A. Test A (By IR) | The IR absorption spectrum of the sample should be concordant with reference spectrum of Pantoprazole sodium RS or reference spectrum of the standard | |
| B. Test C (Sodium Salt) | A dense white precipitate is formed | |
| 3 | Optical rotation | -0.40° to +0.40° |
| 4 | Related Substance by HPLC | |
| Impurity C | NMT 0.5% | |
| Any other Impurity | NMT 0.5% | |
| Total Impurity | NMT 1.0% | |
| 5 | Heavy Metals | NMT 20 ppm |
| 6 | Water | NLT 5.0% & NMT 8.0% |
| 7 | Assay by HPLC (On Dried Basis) | NLT 98.0% & NMT 102.0% |
Storage : Store at room temperature in an airtight container, protected form light
PANTOPRAZOLE SODIUM USP
| Sr No | Tests | Specifications |
|---|---|---|
| 1 | Description | A white to off white powder |
| 2 | Identification | |
| A. By IR | The IR absorption spectrum of the sample should be concordant with reference spectrum of Pantoprazole sodium RS or reference spectrum | |
| B. By Chemical test (Sodium Salt) | A dense white precipitate is formed | |
| 3 | Solubility | |
| In Water | Freely Soluble | |
| In Methanol | Freely Soluble | |
| In dehydrated alcohol | Freely Soluble | |
| In Hexane | Practically insoluble | |
| In Dichloromethane | Practically insoluble | |
| 4 | Heavy Metals | NMT 20 ppm |
| 5 | Water | Between 4.5% and 8.0% |
| 6 | Organic Impurities (By HPLC) | |
| Related Compound A | NMT 0.20 % | |
| Related Compound B | NMT 0.15% | |
| Related Compound C | NMT 0.10% | |
| Related Compound D&F | NMT 0.20% | |
| Related Compound E | NMT 0.10% | |
| Any other individual impurity | NMT 0.10% | |
| Total Impurity | NMT 0.5 % | |
| 7 | Assay (By HPLC) | Not less than 98.0% and Not more than 102.0% (On anhydrous basis) |
Storage : Store at room temperature in a well closed light resistant container
Pantoprazole Sodium API / Powder – Supplier / Manufacturer
