Tulathromycin
Chemical Name | :Tulathromycin A |
Category | :Antibiotics |
Specification | :In-House, Min 98% |
HS Code | :2941.9090.90 |
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Structure Formula | :![]() |
CAS Number | :280755-12-6 |
Molecular Formula | :C41H79N3O12 |
Usage | :Acyclovir is used to decrease pain and speed the healing of sores or blisters in people who have varicella (chickenpox)), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), and first-time or repeat outbreaks of genital herpes (a herpes virus infection that causes sores to form around the genitals and rectum from time to time). Acyclovir is also sometimes used to prevent outbreaks of genital herpes in people who are infected with the virus. Acyclovir is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the body. Acyclovir will not cure genital herpes and may not stop the spread of genital herpes to other people. |
Items | Standar |
---|---|
Appearance | White or off-white powder |
Identification | 1)The IR absorption spectrum of the substance to be examined corresponds to that of the reference standard. 2)The retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that of the principal peak in the chromatogram obtained with reference solution,as obtained in the assay. |
Specific rotation (anhydrous and solvent-free) | -22°~ -26° |
Water | ≤0.5% |
Demethyl-azithromycin | ≤0.5% |
Structural isomer of tulathromycin | ≤0.50% |
Enantiomer of tulathromycin | ≤0.50% |
Impurity 1 | ≤0.20% |
Impurity 2 | ≤0.20% |
Impurity 3 | ≤0.20% |
Impurity 4 | ≤0.20% |
Any individual unknown impurity | ≤0.20% |
Total impurity | ≤6.0% |
Residue on ignition | ≤0.1% |
Heavy metal | ≤0.0020% |
Bacterial endotoxin (Tulathromycin) | <2EU/mg |
Bacterial count | ≤1000cfu/g |
Yeasts and mould count | ≤100cfu/g |
Escherichia coli | Not detectable |
Methanol | ≤0.30% |
Ethanol | ≤0.50% |
Acetone | ≤0.50% |
Methylene dichloride | ≤0.06% |
Isopropanol | ≤0.50% |
Tetrahydrofuran | ≤0.072% |
N-heptane | ≤0.50% |
Dimethyl sulfoxide | ≤0.50% |
Triethylamine | ≤0.032% |
N-propylamin | ≤0.025% |
Residue of palladium | ≤0.0001% |
Sulfate Assay(anhydrous and solvent-free) | Study(≤0.02%) Sum of tulathromycin and structural isomer of tulathromycin:95.0%~103.0% |
1, Argentinian National Institute of Drugs
Instituto Nacional de Medicamentos (INAME)
2, Australian Therapeutic Goods Administration (TGA)
3, Belgian Federal Agency for Medicines and Health Products
Agence Fédérale des Médicaments et des Produits de Santé(AFMPS)
Federaal Agentschap voor Geneesmiddelen enGezondheidsproducten (FAGG)
4, Canadian Health Products and Food Branch Inspectorate(HPFBI)
5, Taiwan Food and Drug Administration (TFDA)
7, Czech State Institute for Drug Control
Státní Ústav pro Kontrolu Léčiv (SÚKL)
8, Czech Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM)
9, Danish Health and Medicines Authority (DHMA)
10, Finnish Medicines Agency (FIMEA)
11, French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
12, French Agency for Food, Environmental & Occupational Health Safety
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)
13, German Federal Ministry of Health *
Bundesministerium für Gesundheit (BMG)
14, Icelandic Medicines Agency (IMA)
20, Indonesian National Agency for Drug and Food Control (NADFC)
21, Health Products Regulatory Authority (HPRA)
22, Italian Medicines Agency
Agenzia Italiana del Farmaco (AIFA)
23, Japanese Pharmaceuticals and Medical Devices Agency(PMDA)
24, Korea (Republic of) Ministry of Food and Drug Safety (MFDS)
25, Malaysian National Pharmaceutical Control Bureau (NPCB)
26, Dutch Health Care Inspectorate*
Inspectie voor de Gezondheidszorg (IGZ)
27, New Zealand's Medicines and Medical Devices Safety Authority (Medsafe)
28, Norwegian Medicines Agency (NOMA)
29, Polish Main Pharmaceutical Inspectorate (MPI)
30, Romanian National Agency for Medicines and MedicalDevices (NAMMD)
31, South African Medicines Control Council (MCC)
32, Spanish Agency of Medicines and Medical Devices *
Agencia Española de Medicamentos y Productos Sanitarios(AEMPS)
33, Swedish Medical Products Agency (MPA)
34, United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA)
35, United Kingdom's Veterinary Medicine Directorate (VMD)
36, U.S. Food and Drug Administration (US FDA)
37, European Directorate for the Quality of Medicines & HealthCare (EDQM)
38, European Medicines Agency(EMA)
39, World Health Organization(WHO)