Thẩm quy trình sản xuất thuốc tiêm đông khô pantoprazol tại c.ty cổ phần dược phâm tư i

• Tác giả: Minh Ngọc Đào, Thị Thu Hằng Lê, Đăng Hoà Nguyễn, Văn Long Nguyễn, Xuân Chung Phạm, Diệu Linh Tăng
• Ngôn ngữ: vie
• Ký hiệu phân loại: 660 Chemical engineering and related technologies
• Thông tin xuất bản: Dược học, 2012
• Mô tả vật lý: 11-14
• Bộ sưu tập: Metadata
• ID: 481875

Tóm tắt

Pantoprazole injectable powder 40mg/vial (PIP) was formulated and prepared at laboratory scale. Manufacturing process of 4100 vials/batch were evaluated on 03 batches in the PHARBACO company. Quality assessment and DSC analysis showed that the obtained product (PIP 40mg/vial) manufactured with the proposed API source (active pharmaceutical ingredients), excipients, formula, manufacturing process and technical parameters were uniform in quality and met the domestic quality specifications licensed by the Ministry of Health.