Documentation

Everything you need to use Pure Monograph for pharmaceutical intelligence, CTD due diligence, and regulatory compliance analysis.

Quick Start

Pure Monograph gives you instant access to pharmaceutical intelligence powered by AI. Here's how to get started in 60 seconds:

1. Create a free account — click "Start Free" on the homepage. No credit card required.
2. Open the Dashboard — choose a preset product or type any drug name.
3. Select your sources — toggle USP, BP, Ph. Eur., and/or JP pharmacopeias.
4. Run your analysis — click Analyze to get compliance scores, gap reports, and remediation steps with full citations.
5. Ask the AI — use the chat widget for any pharmaceutical question. Our AI is trained on regulatory guidelines, pharmacopeial standards, and drug development best practices.

Dashboard Guide

The CTD Due Diligence Dashboard operates in three modes:

Preset Mode

Pre-loaded products (Warfarin, Metformin, Omeprazole, Amlodipine, Lisinopril) with real monograph specifications from USP. Select a product and click Analyze to see compliance results immediately.

Custom Mode

Enter any drug product name. The system applies default specification ranges based on standard pharmacopeial requirements. Useful for quick assessments of products not in the preset library.

Live FDA Mode

Searches the openFDA drug database in real-time across 20,000+ approved products. Returns actual FDA label data including active ingredients, routes, dosage forms, and marketing status.

CTD Modules

Pure Monograph covers all 5 CTD (Common Technical Document) modules with deep analysis of Module 3 Quality:

Module	Coverage	Checkpoints
Module 1 — Administrative	Regional requirements, cover letters, application forms	Completeness check
Module 2 — Summaries	Quality Overall Summary (QOS), nonclinical/clinical overviews	Cross-reference validation
Module 3 — Quality	Drug substance (S) + Drug product (P) — 12 sub-sections	Full compliance scoring
Module 4 — Nonclinical	Pharmacology, pharmacokinetics, toxicology	Study completeness
Module 5 — Clinical	Clinical study reports, literature references	Data integrity check

Module 3 Quality Checkpoints (12 sub-sections)

Each checkpoint is scored against the selected pharmacopeial sources:

• 3.2.S.1 — General Information (nomenclature, structure)
• 3.2.S.2 — Manufacture (synthesis, process controls)
• 3.2.S.3 — Characterisation (elucidation, impurities)
• 3.2.S.4 — Control of Drug Substance (specs, analytical methods)
• 3.2.S.5 — Reference Standards
• 3.2.S.6 — Container Closure System
• 3.2.S.7 — Stability
• 3.2.P.1 — Description and Composition
• 3.2.P.2 — Pharmaceutical Development
• 3.2.P.3 — Manufacture (batch formula, process)
• 3.2.P.4 — Control of Excipients
• 3.2.P.5 — Control of Drug Product (dissolution, stability)

Data Sources

Pure Monograph searches across authoritative pharmaceutical databases:

Source	Type	Coverage
openFDA	Regulatory	20,000+ approved drug products, labels, adverse events
USP-NF	Pharmacopeia	U.S. Pharmacopeia monographs and general chapters
BP	Pharmacopeia	British Pharmacopoeia standards
Ph. Eur.	Pharmacopeia	European Pharmacopoeia monographs
JP	Pharmacopeia	Japanese Pharmacopoeia standards
PubMed	Literature	35M+ biomedical articles
ChEMBL	Chemical	2.3M+ bioactive molecules
ICH Guidelines	Regulatory	Q1-Q14, E-series, S-series harmonized guidelines
FDA Guidances	Regulatory	CMC, bioequivalence, SUPAC, process validation
EMA	Regulatory	European Medicines Agency scientific guidelines

Compliance Scoring

Each quality checkpoint receives a compliance score (0–100%) based on:

• Specification alignment — does the product meet monograph limits?
• Documentation completeness — are all required data points present?
• Cross-pharmacopeial consistency — agreement across USP/BP/Ph.Eur./JP
• Regulatory requirement coverage — ICH, FDA, EMA guideline compliance

Scores are color-coded: Green (≥85%) = Compliant, Amber (60–84%) = Gaps Found, Red (<60%) = Major Gaps.

AI Chat

The AI chat widget (bottom-right corner) lets you ask pharmaceutical questions in natural language. Powered by Grok, it's trained on regulatory guidelines and pharmacopeial standards.

Example questions:

• "What are the USP dissolution requirements for immediate-release tablets?"
• "What stability studies does ICH Q1A require for Zone IVb?"
• "Compare FDA and EMA requirements for bioequivalence waivers"
• "What impurity limits apply under ICH Q3B for a 100mg dose?"

API Authentication

API access is available on Individual plans and above. Generate your API key from Settings.

curl -H "Authorization: Bearer YOUR_API_KEY" \
     https://puremonograph.ai/api/search?q=metformin

Search Endpoint

GET /api/search?q={query}&source={fda|usp|all}

Response:
{
  "results": [...],
  "count": 42,
  "source": "openFDA",
  "cached": false
}

Reports Endpoint

POST /api/reports
{
  "product_name": "Metformin HCl",
  "report_type": "gap_analysis",
  "sources": ["USP", "BP"]
}

GET /api/reports          — list your reports
GET /api/reports/{id}     — get specific report
DELETE /api/reports/{id}  — delete report

Chat Endpoint

POST /api/chat
{
  "message": "What are ICH Q1A stability conditions?",
  "history": []
}

Response:
{
  "response": "According to ICH Q1A(R2)..."
}

Plans & Pricing

Feature	Free	Individual ($99/mo)	Corporate ($499/mo)	Enterprise
Dashboard queries/day	50	Unlimited	Unlimited	Unlimited
AI chat messages/day	10	Unlimited	Unlimited	Unlimited
Saved reports	5	50	Unlimited	Unlimited
PDF export	—	✓	✓	✓
API access	—	✓	✓	✓
Team members	1	1	5	Custom
Proprietary archive	—	—	✓	✓
Support	Community	Email	Priority + calls	Dedicated

Rate Limits

Rate limits are enforced per user account to ensure fair usage:

Plan	Dashboard	AI Chat	API
Free	50/day	10/day	N/A
Individual	500/day	Unlimited	100/min
Corporate	Unlimited	Unlimited	300/min
Enterprise	Unlimited	Unlimited	Custom

Support

Need help? Here's how to reach us:

• Email: info@puremonograph.ai
• Enterprise: enterprise@puremonograph.ai
• AI Chat: Ask the chat widget any question about the platform

Pure Monograph is built by Pure Monograph AI Ltd. in Vancouver, BC, Canada.