can I mix two different raw material batches activity pharmaceutical ingredient

It is generally not recommended to mix two different raw material batches when producing an active pharmaceutical ingredient (API). Here are a few key reasons why:

- Raw material variability can significantly impact the quality and consistency of the final API[2]. Mixing batches with different properties like particle size, flowability, or surface energy could lead to inconsistencies in the API.

- Strict regulations like ICH Q7 require thorough consideration of raw material variability during API manufacturing[3]. Mixing batches may introduce uncontrolled variables that could violate good manufacturing practices (GMP).

- The API manufacturing process is designed and validated based on specific raw materials. Introducing different raw materials could impact the chemical reactions, purification steps, and final API quality attributes[4].

- Traceability and documentation are critical for APIs. Mixing batches makes it harder to track the origin and history of the raw materials used in each API batch[3].

- Acceptance criteria and specifications are set for each raw material batch. Mixing batches could result in a composite that does not meet the required specifications[3].

In summary, while it may be possible to mix raw material batches in some cases, it is generally not recommended due to the potential impact on API quality, consistency, and regulatory compliance. The safest approach is to use a single qualified raw material batch for each API manufacturing run[1][4][5].

Citations:

[1] Pharmaceutical raw materials - FUJIFILM Wako Chemicals https://labchem-wako.fujifilm.com/us/pharmaceutical-raw-materials/medicine/material.html

[2] Raw material variability of an active pharmaceutical ingredient and its ... https://www.sciencedirect.com/science/article/abs/pii/S0939641117312882

[3] Guidance for Industry, Q7A Good Manufacturing Practice ... - FDA https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients

[4] Active Pharmaceuticals Ingredients and Excipients in Pharmaceuticals https://veeprho.com/active-pharmaceuticals-ingredients-and-excipients-in-pharmaceuticals/

[5] What is an API？Difference among API, raw material and intermediate https://www.katsura-chemical.co.jp/en/drugs/