42
Risk Score

Amoxicillin Trihydrate Capsules 500mg

PharmaCare Solutions Ltd.

ACTIVE Batch: AMX-2024-090 Manufactured: 2024-03-10 Expires: 2026-03-09
AI Quality Summary
GOOD
Overall Quality
AI Confidence: 92%
Based on 45+ parameters

This batch shows excellent test results with minor temperature excursions during transit that were within acceptable limits.

Note: Monitor dissolution rates during remaining shelf life
Stability Prediction
95% Potency at EXP
Predicted to maintain >90% potency until expiry
Safety & Usage Information
Intended Use:

Antibiotic for treatment of bacterial infections including respiratory tract infections, urinary tract infections, and skin infections.

Dosage Form:

Oral Capsules, 500mg strength

Important Safety Notes:
  • For prescription use only
  • Take with or without food
  • Complete full course as prescribed
  • Store below 30°C in dry place
  • Keep out of reach of children
View COA

Complete Certificate of Analysis

Temperature Log

Storage & transit history

Authenticity Check

Verify product authenticity

Batch Details
Batch Size: 50,000 units
Manufacturing Site: Plant A, Mumbai
API Source: ChemCorp International
Package Type: Blister packs, 10x10
Storage Conditions: 15-30°C, protected from moisture
Shelf Life: 24 months
QC Release Date: 2024-03-15
Released By: Dr. Priya Sharma
Recall Status
NO ACTIVE RECALL

This batch is currently in distribution and approved for use.

Batch QR Code
Batch QR Code
Scan to verify authenticity
Test Results Summary
Test Parameter Result Specification Status Trend
Assay (Potency) 98.7% 95.0-105.0% PASS +0.3%
Dissolution (30 min) 89% ≥85% PASS Stable
Residual Solvents 0.02% ≤0.05% PASS -0.01%
Microbial Limits Within limits USP <61> PASS Stable
Uniformity of Weight ±2.1% ±5.0% PASS +0.5%
Related Substances 0.3% ≤0.5% PASS -0.1%
Dissolution Profile
Impurity Trend
Temperature Monitoring
Storage Compliance: 98% within limits
AI Identified Risk Factors
Temperature Excursion Medium
+8°C for 6 hours during transit
Dissolution Rate Low
At lower specification limit
Packaging Integrity None
100% seal integrity verified
Formulation Details
Visibility: Public (configured by company)
Privacy Note: Proprietary ratios and exact quantities are hidden as per company policy.
Active Pharmaceutical Ingredients (API):
Amoxicillin Trihydrate (500mg) Clavulanic Acid (125mg)
Excipients (Inactive Ingredients):
Microcrystalline Cellulose Magnesium Stearate Talc Silicon Dioxide Gelatin (Capsule Shell) Titanium Dioxide Iron Oxide Yellow
Supplier Traceability:
Ingredient Supplier Batch No. COA Status
Amoxicillin Trihydrate ChemCorp International API-AMX-089 Verified
Clavulanic Acid PharmaSource Ltd. API-CLA-022 Verified
Microcrystalline Cellulose Excipient Corp EX-MCC-455 Verified
Visibility Settings
Regulator Access

Full formula and process details are available to verified regulators.

Batch Lifecycle Timeline
Manufacturing Complete
2024-03-10

Batch production completed at Plant A

Operator: Rajesh Kumar | Lot: 45
QC Testing Started
2024-03-12

Initial quality control tests initiated

Lab: QualityMed Labs | Tests: 15 parameters
COA Issued
2024-03-15

Certificate of Analysis approved and signed

Approved by: Dr. Priya Sharma
Shipped to Distributor
2024-03-18

Batch shipped to MediDistributors Pvt Ltd

Tracking: SHIP-789456 | Temperature: OK
Warehouse Storage
2024-03-20

Received at central warehouse

Location: WH-45 | Temperature: 22°C
Distribution to Pharmacies
2024-03-25

Distributed to 15 retail pharmacies

First scan by consumer: 2024-04-05
Audit Log
2024-03-16 14:30

COA viewed by pharmacist

2024-03-18 09:15

Temperature log updated

2024-03-20 11:45

Batch scanned at warehouse

2024-04-05 16:20

First consumer verification scan

2024-04-10 10:30

AI risk assessment updated

Associated Documents
Certificate of Analysis.pdf 2.4 MB
Issued: 2024-03-15 | Digital Signature: Valid
Test Results.xlsx 1.8 MB
Uploaded: 2024-03-12 | Contains: 15 test parameters
Product Label.jpg 850 KB
Scanned: 2024-03-10 | OCR Extracted: Yes
Stability Study.pdf 3.2 MB
Period: 0-24 months | Conditions: 25°C/60%RH
Document Security Status
All documents verified

Digital signatures valid and hashes match

Security Features:
  • AES-256 Encryption
  • Digital Signatures
  • SHA-256 Hashes
  • Audit Trail
Distribution Network
Recipient Type Quantity Date Location Status
MediDistributors Pvt Ltd Distributor 20,000 units 2024-03-18 Mumbai Delivered
HealthPlus Pharmacy Retail Pharmacy 5,000 units 2024-03-25 Delhi In Stock
CareFirst Medicals Retail Pharmacy 3,000 units 2024-03-26 Bangalore In Stock
City Hospital Pharmacy Hospital 8,000 units 2024-03-27 Chennai Partially Used
Wellness Mart Retail Pharmacy 4,000 units 2024-03-28 Hyderabad In Stock
Recall Management
No active recalls

This batch is approved for distribution

Recall History:

No recalls in past 24 months

Performance Analytics
Quality Metrics vs Specifications
Stability Prediction
AI Predictive Insights
Prediction: 95% chance of meeting all specifications until expiry
Key Recommendations:
  • Maintain storage temperature
  • Monitor dissolution at 18 months
  • Shelf life could be extended to 30 months