Documents
Technical documents
What your quality and regulatory teams will ask for, and how to get it. Documents are issued per grade, and certificates of analysis are issued per batch against the consignment you receive.
What we issue
- Technical data sheet TDS
- Composition class, appearance, recommended dispersion and the application parameters for each pan size.
- Safety data sheet MSDS
- Handling, storage and transport information required by your EHS team before material enters the plant.
- Certificate of analysis CoA
- Batch specific test results, issued against the batch number on your consignment.
- Regulatory pack Regulatory
- Polymer identity, compliance statements and the supporting documentation your filing references.
By grade
A certificate of analysis is always batch specific, so it ships with the consignment rather than being published here.
| Grade | System | TDS | MSDS | CoA |
|---|---|---|---|---|
| AQ-Z Wb | Film coating | On request | On request | Per batch |
| AQ-ZWt10 | Film coating | On request | On request | Per batch |
| NaQ-Z1Wb | Film coating | On request | On request | Per batch |
| NaQ-Z1Wt10 | Film coating | On request | On request | Per batch |
| UZ1 | Film coating | On request | On request | Per batch |
| SFC101 | Sugar coating | On request | On request | Per batch |
| ECM-RP347 | Enteric coating | On request | On request | Per batch |
| ECM-RP348 | Enteric coating | On request | On request | Per batch |
| ECPT5 | Enteric coating | On request | On request | Per batch |
| ECMS | Enteric coating | On request | On request | Per batch |
| EC714 | Enteric coating | On request | On request | Per batch |
| SC-401 | Seal and pre-coat | On request | On request | Per batch |
| SC-501 | Seal and pre-coat | On request | On request | Per batch |
| CVS-101 | Moisture barrier | On request | On request | Per batch |
| PA-Wt10 | Moisture barrier | On request | On request | Per batch |
| MB 31RP | Moisture barrier | On request | On request | Per batch |
| AC-8 | Moisture barrier | On request | On request | Per batch |
| MNaq series | Metallic and pearl | On request | On request | Per batch |
| SR100 | Sustained release | On request | On request | Per batch |
| RT-114 | Taste mask | On request | On request | Per batch |
| RT314 | Dissolution | On request | On request | Per batch |
| HR100 | Hygroscopic adsorbent | On request | On request | Per batch |
Tell us which documents your quality team needs at the enquiry stage and they ship with the material rather than being chased afterwards. Write to rglaxpharma@gmail.com or start from the contact page.
Documentation by market
- AfricaBritish Pharmacopoeia and USP are both in common use, with WHO guidance underneath.
- the Middle East and GCCEuropean Pharmacopoeia and USP, with the Gulf states generally following EU expectations.
- Southeast AsiaUSP and BP predominate, with national pharmacopoeias in Indonesia and Vietnam.
- South AsiaBritish Pharmacopoeia predominantly, with USP in use.
- the CIS and Central AsiaState pharmacopoeias alongside European Pharmacopoeia references.
- Latin AmericaUSP predominantly, with the Brazilian Pharmacopoeia applying in Brazil.
- Europe and the United KingdomEuropean Pharmacopoeia, with the British Pharmacopoeia in the United Kingdom.
- North AmericaUSP-NF, with excipient monographs in the National Formulary.
- Australia and New ZealandBritish Pharmacopoeia and European Pharmacopoeia, with USP accepted.
What the documents describe
Metallic gold film coat
Metallic blue DB3012
Aqueous colour film coat
Extra white film coat