Evidence board · mission_id=MSN-0019

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-0019 · 2026-11-13 13:00 UTC · 5 items · only this run

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Mission · MAT-MAN-PAR · SITE-RAL · MSN-0019

Mannitol, parenteral grade (low endotoxin) at Raleigh Drug Product: Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

2026-11-13 13:06 UTC

Auto-approved; 4 quotes; 1 attempt(s); checks 6/7; batches 27/27 feasible.

Status: completed
Approval: auto
Transfer: 302 from SITE-COR, ~7 days
Purchase: 280 from Kestrel Polyols (RFQ-121), 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-121
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 fail sourcing: "only SUP-004's quote lands by the need-by date of 2026-10-17 ... SUP-006 (Q-0261) at 9 days lands ~2026-10-26" (the other three quotes "do not land in time"); sourcing: "quote Q-0262, at $22.7489/kg landed USD ($13,239.87 total for 582 kg)"

QA packet · MAT-MAN-PAR · SITE-RAL · MSN-0019

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

2026-11-13 13:04 UTC

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-0019

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

2026-11-13 13:04 UTC

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

Batch	Start	Need	Released
VX201-RAL-AF1-001	10-18	16	90	ok
MB114-RAL-LY1-001	10-20	20	74	ok
VX201-RAL-AF1-002	10-22	16	54	ok
MB114-RAL-LY1-002	10-25	20	38	ok
VX201-RAL-AF1-003	10-26	16	320	ok
VX201-RAL-AF1-004	10-30	16	304	ok
MB114-RAL-LY1-003	10-30	20	288	ok
VX201-RAL-AF1-005	11-03	16	268	ok
MB114-RAL-LY1-004	11-04	20	252	ok
VX201-RAL-AF1-006	11-07	16	232	ok
MB114-RAL-LY1-005	11-09	20	216	ok
VX201-RAL-AF1-007	11-11	16	196	ok
MB114-RAL-LY1-006	11-14	20	460	ok
VX201-RAL-AF1-008	11-15	16	440	ok
VX201-RAL-AF1-009	11-19	16	424	ok
MB114-RAL-LY1-007	11-19	20	408	ok
VX201-RAL-AF1-010	11-23	16	388	ok
MB114-RAL-LY1-008	11-24	20	372	ok
VX201-RAL-AF1-011	11-27	16	352	ok
MB114-RAL-LY1-009	11-29	20	336	ok
VX201-RAL-AF1-012	12-01	16	316	ok
MB114-RAL-LY1-010	12-04	20	300	ok
VX201-RAL-AF1-013	12-05	16	280	ok
VX201-RAL-AF1-014	12-09	16	264	ok
MB114-RAL-LY1-011	12-09	20	248	ok
VX201-RAL-AF1-015	12-13	16	228	ok
MB114-RAL-LY1-012	12-14	20	212	ok

Supplier evidence · MAT-MAN-PAR · MSN-0019

Supplier evidence: Mannitol, parenteral grade (low endotoxin)

2026-11-13 13:00 UTC

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
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
Pharmacompass (directory listing) directory
List of all Manufacturers, Suppliers & Exporters of Mannitol API listed on PharmaCompass with details of regulatory filings ... View All Manufacturers & Suppliers of Mannitol Excipients with Drug Master Files (DMF), CEP/COS, Japanese DMFs,
Pharmaoffer (directory listing) directory
Compare 21 Mannitol API suppliers from China, India and Japan. Check GMP, CEP and US DMF status and request a quote directly - free on Pharmaoffer. ... Mannitol (Diuretics, CAS 69-65-8) is offered by 21 suppliers on Pharmaoffer - 14 produce
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
Drug Dev supplier_site
Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP, ICH Q7 ... Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/
Prnewswire supplier_site
/PRNewswire/ -- Pfanstiehl has announced the launch of a new high purity, low endotoxin, Mannitol (USP/NF, EP, JP), manufactured in the US under strict cGMP,... ... 1, 2014 /PRNewswire/ -- Pfanstiehl has announced the launch of a new high p
pharma excipients (directory listing) directory
Low-endoxin carbohydrates, polysaccharides and oligosaccharides incl. Trehalose, Sucralose, Mannitol, Mannose, Maltose for injectable formulations. ... Pfanstiehl specializes in isolation, purification, custom synthesis and scale-up develop
Clyzo supplier_site
Clyzo provides pharmaceutical D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade excipient to the pharmaceutical industry at the best prices. Buy D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade e
AdvaCare Pharma supplier_site
Mannitol Injection is a drug that is used to reduce intracranial and intraocular pressure. It is used in the treatment of cerebral edema and renal failure. ... Mannitol Injection is an osmotic diuretic for parenteral administration. AdvaCar

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.fishersci.com/shop/products/carbohydrate-excipientand-1kg-3/www.pharmacompass.com/manufacturers-suppliers-exporters/mannitol pharmaoffer.com/api-excipient-supplier/diuretics/mannitol www.roquette.com/pharma-and-nutraceuticals-mannitol-pyrogen-free drug-dev.com/pfanstiehl-launches-cgmp-produced-parenteral-grade-

Material dossier · MAT-MAN-PAR · MSN-0019

Dossier: Mannitol, parenteral grade (low endotoxin)

2026-11-13 13:00 UTC

PubChem CID: 6251
Formula: C6H14O6
Mol. weight: 182.17
CAS: 69-65-8, 87-78-5, 133-43-7
XLogP: -3.1
GHS: Not Classified
IUPAC: (2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexol

Our spec

Grade: parenteral low-endotoxin
Compendia: USP-NF, Ph. Eur., JP
Storage: 15-25 C, dry, protected from light
Shelf life: 1095 days
Sourcing: spec_led
QC release: 7 days

Approved suppliers

Kestrel Polyols SUP-004 · released_for_use · CEP
Brightwater Sugars SUP-003 · released_for_use
Halvard Fine Chemicals SUP-005 · quality_approved · CEP
Corrib Pharma Supply SUP-006 · quality_approved · DMF, CEP

Sourcespubchem.ncbi.nlm.nih.gov/rest/pug/compound/name/mannitol/propert pubchem.ncbi.nlm.nih.gov/rest/pug/compound/cid/6251/synonyms/JSO pubchem.ncbi.nlm.nih.gov/rest/pug_view/data/compound/6251/JSON?h pubchem.ncbi.nlm.nih.gov/compound/6251