Liraglutide
Brief Introduction:
Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue for blood glucose control in adults with type Ⅱ diabetes.
Specifications of our Liraglutide:
| Test Items | Specifications |
| Appearance | White or almost white loose powder |
| Solubility | Freely soluble in water, soluble in methanol, very slightly soluble in ethanol |
| Hygroscopicity | Hygroscopic |
| Specific optical rotation | -15.0° to -30.0°(on the anhydrous and sodium ion-free substance, c=10mg/ml in water at 25℃) |
| Identification(By HPLC) | The retention time of Liraglutide peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. |
| Molecular Ion Mass | 3751.29 |
| Amino acid Content | Asp: 0.9 ~ 1.1 |
| Glu: 4.5 ~ 5.5 | |
| Ser: 2.7 ~ 3.3 | |
| Gly: 3.6 ~ 4.4 | |
| His: 0.9 ~ 1.1 | |
| Arg: 1.8 ~ 2.2 | |
| Thr: 1.8 ~ 2.2 | |
| Ala: 3.6 ~ 4.4 | |
| Aib: 0.9 ~ 1.1 | |
| Tyr: 0.9 ~ 1.1 | |
| Val: 1.8 ~ 2.2 | |
| Lys: 0.9 ~ 1.1 | |
| Ile: 0.9 ~ 1.1 | |
| Leu: 1.8 ~ 2.2 | |
| Phe: 1.8 ~ 2.2 | |
| pH Value | 8.7 ~ 9.5 |
| Water Content(K. F) | Not more than 8.0% |
| The clarity and colour of the solution | Clear and colourless |
| Related Substances(HPLC) | Maximum single impurity: ≤1.0% |
| Total impurities: ≤2.0% | |
| High molecular protein | Not more than 0.5% |
| Residual Solvents Ⅰ | Methylene Chloride: ≤600ppm |
| Acetonitrile: ≤410ppm | |
| Methanol: ≤3000ppm | |
| Isopropyl ether: ≤5000ppm | |
| Residual Solvents Ⅱ | N,N-Dimethylformamide: ≤880ppm |
| Bacterial Endotoxins | Not more than 10EU/mg |
| Microbial Limits | TAMC: ≤200CFU/g |
| TYMC: ≤100CFU/g | |
| Sodium ion | 2.0% ~ 4.0% |
| Assay(C172H265N43O51) | 95.0% ~ 105.0% (Calculated with reference to the anhydrous and sodium ion-free substance.) |
| Acid Group Ions | Trifluoroacetate ion(TFA): ≤0.1% |
| Chloride ion: ≤0.1% |
Usage and Dosage:
♔ Usage
This product should be injected once a day, and it can be injected at any time, and it does not need to be administered according to the meal time. This product is administered by subcutaneous injection, and the abdomen, thigh or upper arm can be selected as the injection site. No dose adjustment is required when changing the injection site and time. However, it is recommended that this product be injected at the same time every day, and the most convenient time of day should be chosen. For more guidance on administration, please refer to Precautions for Use and Other Operations.
This product cannot be injected intravenously or intramuscularly.
♔ Dosage
The starting dose of Liraglutide is 0.6 mg per day. After at least 1 week, the dose should be increased to 1.2 mg. Some patients are expected to benefit from increasing the dose from 1.2 mg to 1.8 mg, according to the clinical response, in order to further improve the hypoglycemic effect, the dose can be increased to 1.8 mg after at least one week. But it is recommended that the daily dose should not exceed 1.8 mg.
This product can be used in combination therapy with metformin without changing the dose of metformin.
This product can be used in combination therapy with sulfonylureas. When this product is used in combination with sulfonylureas, consideration should be given to reducing the dose of sulfonylureas to reduce the risk of hypoglycemia (see Precautions).
When adjusting the dose of this product, self-monitoring of blood glucose is not required. However, when the product is combined with sulfonylureas and the dose of sulfonylureas is adjusted, self-monitoring of blood glucose may be required.
Packaging:
1g/bottle, 5g/bottle or according to the specific requirements from customers.
Storage Conditions:
Kept in tight containers, protected from light, stored at a temperature of -20±5℃.
Shelf Life:
24 months after manufacturing date if stored under above mentioned conditions.
