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Compliance with Ph.Eur. monograph 2088; purity min 97.0% (related substances < 0.5% individual, < 1.0% total by HPLC); water content 4.0-5.0% by KF; specific optical rotation within Ph.Eur. limits; EDQM CEP required or under filing with firm timeline; EU GMP certified manufacturing facility
Netherlands importer requires CEP-registered supplier. Will consider supplier with CEP application filed if firm EDQM assessment timeline is provided. Annual volume: 80 MT. Quality agreement required. On-site audit by Netherlands buyer QA team required within 6 months of first shipment.
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