Appearance: White or almost white crystalline powder
Melting Point: 168°C to 172°C
Loss on Drying: <= 0.5% (105°C, 3 hours)
Residue on Ignition (Sulfated Ash): <= 0.1%
Heavy Metals: <= 10 ppm
Particle Size Distribution (PSD):
Standard Grade: d90 < 250 um
Direct Compression (DC) Grade: d90 < 150 um (optimized for flowability and compressibility without capping)
Residual Solvents: Compliant with ICH Q3C guidelines (Ethanol <= 5000 ppm, Methanol <= 3000 ppm)
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Chemical Name |
N-(4-hydroxyphenyl)acetamide |
|
CAS Registry Number |
103-90-2 |
|
Molecular Formula |
C8H9NO2 |
|
Molecular Weight |
151.16 g/mol |
|
Pharmacopeial Compliance |
USP / EP / JP |
|
Assay (Dried Basis) |
98.0% - 101.0% |
|
Identification |
Infrared Absorption (IR) matches reference standard; Positive HPLC retention time |
Oral Solid Dosage Forms:
Raw material for immediate-release and extended-release tablets, caplets, and hard gelatin capsules.
Liquid Formulations:
Active component in pediatric syrups, elixirs, and intravenous (IV) infusion formulations requiring low endotoxin profiles.
Combination Formulations:
Co-formulated with NSAIDs, antihistamines, and decongestants for multi-symptom cold and flu remedies.
Impurity Control: Controlled according to ICH Q3A/Q3B thresholds. Related substances (e.g., 4-aminophenol <= 50 ppm, chloroacetamide derivatives undeletable by HPLC) are minimized to prevent degradation and toxicological risks during shelf-life storage.
Flowability and Compressibility: DC-grade variants exhibit optimized bulk density (0.45 g/cm3 - 0.60 g/cm3) and angle of repose (<= 30°), minimizing tablet weight variation and die-sticking during high-speed rotary press operations (> 50,000 tablets/hour).
Polymorphic Stability: Formulated in stable Form I monoclinic crystalline structure, preventing phase transformation during wet granulation drying cycles.
Testing Protocols:
Every production batch is tested via HPLC, FTIR, GC (for residual solvents), and atomic absorption spectroscopy (for heavy metals) prior to release.
Reference Standards:
Analytical testing validated against USP and EP primary reference standards.
Data Integrity:
Laboratory systems adhere to 21 CFR Part 11 requirements, featuring secure, unalterable audit trails for all chromatographic and analytical raw data.
Available Grades: USP Grade, EP Grade, JP Grade, and Custom Micronized Grades.
Regulatory Documentation Support: Drug Master File (DMF) available for US FDA and EDQM reference. Letters of Access (LoA) provided upon commercial agreement.
Pharmacopeial Audit Trail: Manufactured in facilities audited by international regulatory bodies, maintaining complete audit logs for raw material sourcing, intermediate synthesis, and final micronization.
Technical Documents
COA
Lot-specific Certificate of Analysis detailing actual numerical assay values, exact impurity percentages, moisture content, particle size distribution, and microbial limits. Downloadable sample COA available through the secure document portal.
SDS
Safety Data Sheet conforming to GHS standards, detailing occupational exposure limits, handling precautions, acute toxicity data, and spill response procedures.
TDS
Technical Data Sheet summarizing physical specifications, recommended processing parameters, storage instructions, and packaging configurations for technical evaluation.
Packaging Configuration: Double-layer medical-grade low-density polyethylene (LDPE) inner bags tied securely, sealed within a fiber drum or rigid HDPE drum with tamper-evident seals.
Standard Net Weight: 25 kg / drum (Custom bulk packaging available for recurring commercial orders).
Storage Conditions: Store below 25°C in a dry, well-ventilated area. Keep away from direct sunlight, moisture, and oxidizing agents.
Shelf Life: 36 months from the date of manufacture when stored in unopened, original containers under specified conditions.
Minimum Order Quantity (MOQ):
100 kg (Commercial trial batches of 25 kg available for R&D evaluation).
Bulk Supply Stability:
Ex-stock standard grades: Dispatch within 5 to 7 business days.
Scheduled production lots: 3 to 4 weeks FOB port of export.
Sample Policy:
100g - 500g analytical reference samples provided to qualified corporate entities for laboratory testing and method validation.
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Annual volume commitments supported by validated dual-sourcing supply chains and dedicated safety stock inventories maintained at regional distribution hubs.
Custom Particle Sizing: Tailored micronization services available to adjust d50 and d90 ranges to match specific dissolution profile requirements.
Private Labeling & Packaging: Custom drum labeling, barcoding (GS1-128 compliance), and client-specified documentation headers available for long-term supply agreements.
To receive a formal commercial quotation including current tier-based pricing, shipping terms (FOB/CIF), and lot-specific documentation, submit your required annual volume, destination port, and grade specifications through the corporate inquiry portal.
As one of the most professional pharmaceutical raw materials manufacturers and suppliers in China, we're featured by quality products and good service. Please feel free to buy high-grade pharmaceutical raw materials from our factory. For price consultation, contact us.
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