关于制药方面的，求高人帮我翻译一段话，谢谢

Question

The potential and actual impurities of CHEMICAL-X have been investigated. The materials that have been considered as possible sources of impurities are the synthesis starting materials and process intermediates, compounds arising from side reactions or related to impurities in starting materials, other process reagents and solvents, and the potential degradation products of CHEMICAL-X. The presence of these materials was investigated in typical lots of intermediates and drug substance using the regulatory HPLC method For CHEMICAL-X and other appropriate testing procedures.

The establishment of appropriate raw material specifications and in-process control testing has been shown to adequately control the occurrence of undesired impurities within suitable levels. In actual lots of CHEMICAL-X produced and exZZZned thus far, no impurities other than the related substance and residual solvents regulated by the drug substance specifications have been present at levels above the limit of quantitation of the analytical methods.

The names, structures and sources of the related substance that have been identified are summarized in Table 3.e.
The specifications for related substances in CHEMICAL-X have been established to be consistent with the ICH threshold for qualification (0.15%) for known impurities and threshold for identification (0.10%) for unknown impurities. The limit for known impurities is in all cases well below the levels qualified on the basis of general toxicity results.
Two different spectroscopic techniques are applied to provide independent confirmation of identity. An isocratic HPLC procedure is used for assay of the drug substance, and a related procedural modification with gradient elution is used for determination of all related substances except the enantiomer. The limits for related substances of not more than 0.15% fro each of 4 specified compounds and not more than 0.10% for any other single related substance correspond to the ICH qualification threshold for the 4 known impurities and the identification threshold fro unknown impurities. On that basis, no further supportive evidence fro impurity qualification is necessary. A chiral HPLC method is used for quantitative determination of the enantiomer of CHENICAL-X. The limit of not more than 0.15% that is also adopted for the enantiomer content complies with the recommended qualification threshold of ICH guidance Q3A for related substances. A particle size specification has been implemented to control both the mean size and distribution of sizes, based on experimental results obtained with tablets made from drug substance over a wide range of sizes. Inclusion od additional tests fro heavy metals, residue on ignition and residual solvents provides the necessary control over other aspects of purity to assure overt batch-to-batch consistency.

Answer 1

化学X的潜在的和实际的杂质进行了调查。那些被认为是可能的来源杂质的合成材料和工艺的中间体原料，化合物所产生的不良反应或相关起始原料，试剂和溶剂等过程，以及化学- X的潜在降解产物对杂质。这些物质中的中间体进行了研究和使用的监管高效液相色谱法测定化学X和其他适当的检测程序，方法，原料药的典型地段。

适当的原料规格和过程控制检验成立以来，一直表现出充分的控制在适当的级别上不受欢迎的杂质发生。在化学- X的实际生产和exZZZned地段迄今，无杂质比相关物质和原料药的规格调控有机溶剂残留量等已经在上方的分析方法定量限水平存在。

的名称，结构和有关物质的来源已查明的总结于表3.e.
在化学- X的相关物质的规范已经建立必须与资格已知杂质和未知杂质鉴定（0.10％）阈值（0.15％）颅内出血的阈值相一致。对于已知杂质限制在远低于对一般毒性成果的基础上合格水平的所有案件。
两种不同的光谱技术应用到提供身份独立确认。等度高效液相色谱法的程序是用于测定原料药，以及相关的梯度洗脱程序修改除对映体的所有有关物质的测定。有关物质不超过0.15％，来回各4所指明的化合物和不超过0.10的其他任何一个有关物质％的限制对应的非物质文化遗产的资格门槛为4已知杂质和未知杂质鉴定门槛来回。在此基础上，没有进一步的支持性证据来回杂质资格是必要的。手性高效液相色谱法用于对CHENICAL - X的对映体的定量测定。在不超过0.15％的上限，这也是对映体内容为通过符合ICH的指导Q3A推荐资格有关物质的门槛。一个粒子的尺寸规格已经实施同时控制平均尺寸大小和分布的基础上，从原料药作出了广泛的尺寸片获得的实验结果。外径列入额外的测试来回重金属，残留溶剂点火和残留提供了纯度超过其他方面必要的控制，以保证公开批与批之间的一致性。