Erlotinib hydrochloride CAS:183321 74 6 manufacturer/supplier
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- Supplier: Hangzhou Royall Import & Export Co. Ltd. [Zhejiang China]Hangzhou
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Product Overview
Description
Erlotinib hydrochloride (trade name Tarceva) is a drug used to treat non-small cell lung cancer (NSCLC), pancreatic cancer and several other types of cancer. It is a reversible tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR).
TARCEVA (erlotinib), a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)4-quinazolinamine. TARCEVA contains erlotinib as the hydrochloride salt that has the following structural formula:
Erlotinib hydrochloride has the molecular formula C22H23N3O4.HCl and a molecular weight of 429.90. The molecule has a pKa of 5.42 at 25°C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane.
Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2.
TARCEVA tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: lactose monohydrate, hypromellose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate and titanium dioxide. The tablets also contain trace amounts of color additives, including FD&C Yellow #6 (25 mg only) for product identification.
ERLOTINIB HYDROCHLORIDE | ||
PRODUCT IDENTIFICATION | ||
CAS NO. | 183321-74-6 | |
EINECS NO. |
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FORMULA | C22H23N3O4·HCl | |
MOL WT. | 429.90 | |
H.S. CODE |
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TOXICITY |
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SYNONYMS | Tarceva; | |
N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride; 4-(m-Ethynylanilino)- 6,7-bis(2-methoxyethoxy)quinazoline monohydrochloride; N-(3-Ethynylphenyl)-6,7-bis(2-methoxy ethoxy) quinazolin-4-amine hydrochloride; | ||
CLASSIFICATION | Protein Kinase Inhibitor | |
PHYSICAL AND CHEMICAL PROPERTIES | ||
PHYSICAL STATE | white to off-white powder | |
MELTING POINT | 223 - 228 C | |
BOILING POINT |
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RELATIVE DENSITY |
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SOLUBILITY IN WATER | very slightly soluble (slightly soluble in methanol, insoluble in acetonitrile, acetone, ethyl acetate, hexane) | |
pH |
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VAPOR DENSITY |
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REFRACTIVE INDEX |
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NFPA RATINGS |
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AUTOIGNITION |
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FLASH POINT |
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STABILITY | Stable under normal conditions. | |
GENERAL DESCRIPTION & APPLICATIONS | ||
Types of chemotherapy drug;
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SALES SPECIFICATION | ||
APPEARANCE | white to off-white powder | |
IDENTIFICATION | to pass | |
ASSAY | 99.0% | |
HEAVY METALS | 10ppm max | |
LOSS ON DRYING | 0.5% max | |
RESIDUE ON IGNITION | 0.2% max | |
ISOMER | 0.3% max | |
MELTING POINT | 223 - 228 C | |
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