Our fully operational manufacturing plant situated at Khatraj, Gujarat is designed in accordance with the current cGMP norms and by considering the export regulatory market. We ensure that the product quality is never compromised by adopting a single-product policy.
Capacity: About 400 MT/month
Input batch size: Up to 2000 kg
The paracetamol complies with all the essential Pharmacopeia (IP/EP/BP) quality standards. A standard packaging size of 25/50 kg will be offered for paracetamol API. As per your needs, Sibyl Pharmaceuticals provides customized packaging orders.
- Powder form – Tablets
- Suspension (liquid syrups)
- Encapsulated
- Suppositories
- Injectable
As part of our internal quality policy, we are dedicated to continuous improvement for creating products that meet and exceed client needs and expectations.
| Name of Test | Acceptance criteria | ||||
| IP | EP / BP | USP | |||
| 1 | Description | White Crystals or White Crystalline Powder | White, or almost white, Crystalline Powder | White, odorless, Crystalline Powder. | |
| 2 | Solubility | Sparingly soluble in Water, freely soluble in ethanol, very slight solubility in Methylene chloride | Sparingly soluble in Water, freely soluble in ethanol, very slight solubility in Methylene chloride | Freely soluble in Ethyl Alcohol, Soluble in Boiling Water and in 1N NaOH. | |
| 3 | Identification | (A) The absorbance at 249 nm is about 0.44 (B) A violet color develops which does not turn to red. (C) Gives the reaction of acetyl groups. (D) The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Paracetamol working standard. | (A) Result-A Melting Point – 168°C to 172°C. Result-B The absolute difference between the melting point mixture and the value obtained in Determination A (Result-A) is not greater than 2°C (B) The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Paracetamol working standard. | (A) By IR:
The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Acetaminophen working standard. (B) By HPLC: The retention time of the major peak obtained in sample solution corresponds to that obtained in the standard solution, as described in the test of assay. | |
| 4 | Related substance | ||||
| Impurity J | NMT 10 ppm | NMT 10 ppm | – | ||
| Impurity K | NMT 50 ppm | NMT 50 ppm | – | ||
| Impurity F | NMT 0.05 % | – | – | ||
| Unspecified Impurity | – | NMT 0.05 % | NMT 0.05 % | ||
| Total Impurities | NMT 0.1 % | NMT 0.2 % | NMT 0.1 % | ||
| Any other Impurity | NMT 0.05 % | – | – | ||