, also known as diphenylcyproheptadine, analgesic, ethylcyproheptadine, and anti-root, is a hexahydropyridine antihistamine that can compete with histamine released from tissues for H1 receptors on effector cells, thereby preventing the onset of allergic reactions and relieving the spasmodic and congestive effects of histamine. This product has a strong H1 receptor antagonist effect and a strong antihistamine effect. It has mild and moderate anti-5-hydroxytryptamine and anticholinergic effects. In addition, it can stimulate appetite, and weight gain can be seen after taking it for a certain period of time.
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Blanks (without IS) and zero samples (with IS) were analyzed for specificity and selectivity studies. The linearity of the method was determined over the calibration range of 100 ng/ml to 800 ng/ml (Table 3). Calibration standards were prepared by spiking known concentrations of CPH working standard solution. A linear curve containing eight non-zero concentrations was analyzed. (Figure 1) The concentration was calculated for each level and plotted against the area. The slope, y-intercept, and correlation coefficient curves were calculated by linear regression analysis.
As shown in Table 1. Accuracy was measured on samples with known amounts of analyte. Accuracy studies were performed by appropriately diluting and preparing a commercial formulation at a concentration of 100 ng/ml. (Quality Control Samples) Accuracy was determined by performing replicate analyses of six determinations of low (80%), medium (100%), and high (120%) quality control samples. For the 100 ng/ml quality control sample, 80% of the pure API i.e. CPH was spiked, hence 80 ng/ml of API, and similarly for 100% and 120%. The recovery of the spiked API was then checked.

| 98% | 99.54% | |
| NLT 100% Through 80 mesh | ||
| <2.0% | 0.46% | |
| Less than or equal to 10ppm | ||
| Less than or equal to 3ppm | ||
| Less than or equal to 3ppm | ||
| Less than or equal to 1000cfu/g | ||
| Less than or equal to 100cfu/g | ||
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3-7 days |
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Suitable for under 50kg. |
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7-15 days |
Suitable for more than 50kg. |
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15-60 days |
Suitable for more than 500kg. |
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