Evidence board · mission_id=MSN-0007

What the agent looked at

Chemical dossiers, production-line feasibility, QA packets and supplier evidence gathered during missions. Corvane Biologics is fictional and its inventory, schedules and suppliers are synthetic; PubChem and web evidence are live.

Run MSN-0007 · 2026-10-24 13:00 UTC · 4 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0007

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

Auto-approved; 4 quotes; 1 attempt(s); checks 7/7; batches 27/27 feasible.

Status
completed
Approval
auto
Transfer
302 from SITE-COR, ~7 days
Purchase
280 from Kestrel Polyols (RFQ-109), 19 days + 7 days QC
Checks
  • covers_need pass transfer 302 + purchase 280 = 582 vs need 582 kg
  • lands_in_time pass 35 days available after transfer (cover 49.0 d − safety 14 d); chosen lead time 19 d + QC release 7 d = 26 d
  • qualified_only pass Kestrel Polyols is released_for_use
  • comparable_quotes pass 4 usable quotes of 4 received on RFQ-109
  • batches_feasible pass 27/27 batches on LINE-RAL-AF1, LINE-RAL-LY1 have released material at start (transfer released day 9, purchase released day 26)
  • grade_fit pass Kestrel Polyols: parenteral low-endotoxin vs aseptic fill at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; lyophilization at cleanroom grade A: parenteral, low-endotoxin, USP-NF + Ph. Eur.; quality rank 3 of 4
  • grounded pass claims match recomputed facts
QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0007

QA packet: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

QC release
7 days after arrival
Transfer release
2 days (receipt verification)
Change control
not required
Supplier
SUP-004 · released_for_use
Cold chain
no
Storage
15-25 C, dry, protected from light
Grade
parenteral low-endotoxin
Compendia
USP-NF, Ph. Eur., JP
Endotoxin
low
Documents required
  • Certificate of Analysis (CoA)
  • Certificate of Conformance (CoC)
  • CEP reference (SUP-004)
  • Inter-site transfer record with donor-site QA release status
Line feasibility · MAT-MAN-PAR · SITE-RAL · MSN-0007

Line feasibility: Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product

All 27 scheduled batches have released MAT-MAN-PAR at start.

Released now
90 kg
Horizon
60 days from 2026-10-17
Lines
  • LINE-RAL-AF1 Raleigh aseptic filling line 1 · aseptic_fill · grade A
  • LINE-RAL-LY1 Raleigh lyophilisation line 1 · lyophilization · grade A
Inbound
  • transfer 302 kg: arrives 2026-10-24, released 2026-10-26
  • purchase 280 kg: arrives 2026-11-05, released 2026-11-12
BatchStartNeedReleased
VX201-RAL-AF1-00110-181690ok
MB114-RAL-LY1-00110-202074ok
VX201-RAL-AF1-00210-221654ok
MB114-RAL-LY1-00210-252038ok
VX201-RAL-AF1-00310-2616320ok
VX201-RAL-AF1-00410-3016304ok
MB114-RAL-LY1-00310-3020288ok
VX201-RAL-AF1-00511-0316268ok
MB114-RAL-LY1-00411-0420252ok
VX201-RAL-AF1-00611-0716232ok
MB114-RAL-LY1-00511-0920216ok
VX201-RAL-AF1-00711-1116196ok
MB114-RAL-LY1-00611-1420460ok
VX201-RAL-AF1-00811-1516440ok
VX201-RAL-AF1-00911-1916424ok
MB114-RAL-LY1-00711-1920408ok
VX201-RAL-AF1-01011-2316388ok
MB114-RAL-LY1-00811-2420372ok
VX201-RAL-AF1-01111-2716352ok
MB114-RAL-LY1-00911-2920336ok
VX201-RAL-AF1-01212-0116316ok
MB114-RAL-LY1-01012-0420300ok
VX201-RAL-AF1-01312-0516280ok
VX201-RAL-AF1-01412-0916264ok
MB114-RAL-LY1-01112-0920248ok
VX201-RAL-AF1-01512-1316228ok
MB114-RAL-LY1-01212-1420212ok
Supplier evidence · MAT-MAN-PAR · MSN-0007

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

discovery_candidate (not approved)

  • Pfanstiehl supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
    D-Mannitol USP Excipient GMP for Highest Purity, Lowest Endotoxin, Lowest Metals. Best Mannitol for cryoprotection in therapeutic final formulations ... Pfanstiehl Brand High Purity Low Endotoxin Low Metals (HPLE-LM)TM Multi-Compendial D-Ma
  • Pharmacompass (directory listing) directory
    List of all Manufacturers, Suppliers & Exporters of Mannitol (USP) API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol (USP) API with Drug Master Files (DMF), CEP/COS, Japanese D
  • Fishersci supplier_site · page claims: GMP, USP-NF, Ph. Eur., JP, ChP, low endotoxin, parenteral grade
    Pfanstiehl D-Mannitol has been specifically designed and formulated to remove impurities such as endotoxin, trace metals, and nitrosamines. Manufactured in the USA under ICH-Q7 cGMP conditions, Pfanstiehl Mannitol meets parenteral (injectab
  • Pharmaoffer (directory listing) directory
    Find CEP, CoA, DMF, FDA, GMP Certified Mannitol API Suppliers | CAS №: 69-65-8 | Diuretics | Access insights on pricing, market trends, and demand. Compare manufacturers and get quotations directly for free. ... Being a European certificate
  • Roquette supplier_site
    PEARLITOL® PF is a mannitol pyrogen-free used for parenteral preparations and Rx injectables. ... As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectabl
  • Pharma Excipients (directory listing) directory
    Mannitol is typically used in biopharmaceutical formulations as a stabilizer, bulking agent, or lyoprotecting agent. D(-)-Mannitol Emprove® Expert features low ... Mannitol is typically used in biopharmaceutical formulations as a stabilizer

Queries: Mannitol parenteral grade low endotoxin supplier GMP DMF CEP / mannitol parenteral low-endotoxin GMP manufacturer DMF CEP

Sourcespfanstiehl.com/en/high-purity-ingredients/mannitol/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitolwww.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/pharmaoffer.com/api-excipient-supplier/mannitol/cep-coa-dmf-fda-www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-freewww.pharmaexcipients.com/product/d-mannitol-emprove-expert/